Summary: Depuy Hip Replacement Recall
DePuy Hip Replacement Recall
The complaints about defective hip implants made by DePuy Orthopaedics, Inc., a part of Johnson and Johnson’s Medical Devices & Diagnostics group, had been sending to the U.S. Food and Drug Administration over the past two years. On August 24, 2010, after a warning letter from the F.D.A. and the new medical information of these faulty hip implants from the UK National Joint Registry, DePuy finally recalled about 93,000 of these artificial joints. What are the ethical risks and consequences associated with DePuy’s products? What should DePuy do to correct these failures?
DePuy Inc., a member of the Johnson & Johnson Family of Companies, a world leader in health care products and services, was founded in 1895. DePuy Inc. develops and markets products under the DePuy Orthopaedics, Inc.; DePuy Spine, Inc.; Codman & Shurtleff, Inc.; and DePuy Mitek units.
DePuy Orthopaedics Inc. was the first commercial orthopaedics company in the U.S. To become a global leader in orthopaedic devices and supplies, the company has committed to the innovation in patient care and improvement of movement in patients’ lives …show more content…
around the world. DePuy Orthopaedics manufactures more than 200 of joint replacement products that include hip, knee, ankle, finger and shoulder, and operating room products. DePuy Orthopaedics, Inc. and its medical devices & diagnostics group have been developing their technologies, products and services, and addressing some of the most chronic and pervasive conditions, and continuing in their tradition of advancing the standard of healthcare and education, and new treatments and solutions. However, on August 24, 2010, DePuy Orthopaedics and J&J announced recall of two of DePuy hip replacement products, the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System. The DePuy ASR™ Hip Resurfacing System, a rounded bone atop the thigh bone that fits into that socket like a ball, was available outside the U.S. and the ASR™ XL Acetabular System, a hip socket used in traditional hip replacement, was available worldwide.
“The ASR Hip System was designed as an additional option for surgeons in treating patients suffering from severe and disabling arthritis and other diseases of the hip joint. The ASR Hip System was designed and developed in conjunction with experienced orthopaedic surgeons and leaders in the biomedical field. The ASR Hip System was cleared for marketing by the U.S. Food and Drug Administration under the 510k regulatory process established by Congress, which is used for a majority of medical devices on the market. The ASR Hip Resurfacing System was introduced outside the US in 2003. The ASR XL Acetabular System was introduced outside the US in 2004 and in the US in 2005”. (DePuy Companies, 2010)
The DePuy hip replacement recall had begun after the UK National Joint Registry, indicated the high early failure rate of both the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Moreover, the U.S. Food and Drug Administration had been receiving complaints about the failures of these two hip devices over the last few years, even though, the company stated that the majority of hip replacements using the ASR devices had been successful. On average, most hip replacements last for 10 to 20 years depends on the persons and type of activity they do. However, the F.D.A. records show that approximately12 percent of patients who received the DePuy ASR Hip Resurfacing system and 13 percent of patients who received the ASR XL Acetabular System needed a second hip replacement within five years of receiving the ASR implants. In other words, one out of every eight hip replacements with this implant system would fail, often requiring a revision surgery.
“We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality”. (Johnson & Johnson Services, Inc., 1997-2011)
J&J stated in its credo that the organization will provide the high quality of products and services to the customer.
This culture is followed still today to achieve the commitments stated in the Credo. However, the growing number of operating companies continues to grow and put strain on J&J, a parent company. As in this case, defective and unsafe hip implants made by Depuy Ordopaetics, units of J&J, caused problems in patients who used these products. Both two types of Depuy hip implant didn’t have a sufficient screw or cement to be able to hold on to the socket itself, causing dislocation between the two parts of artificial hip joint that move against each other. Patients usually experienced severe pain and swelling and had difficulty walking or inability to walk. These problems were quickly identified through surgery and
x-rays.
Nevertheless, another problem associated with artificial joint had also occurred in some patients. In fact, they are part of a category of implants called metal-on-metal bearings that often degrade and loosen prematurely, which can generate debris from wear, causing flakes of metal to leach into the bloodstream, also inflammation and tissue damage in certain patients. The movement when the metal parts of the implant rubbed against each other caused metal poisoning and a spectrum of health problems ranging from mild to debilitating. The toxic heavy metals known as cobalt and chromium were frequently released into the bloodstream and could destroy the bone and issue surrounding the implant, a condition known as metallosis , and that when the device failed and patient needed a second hip replacement procedure.
So many people had questioned that if these devices have been tested or were well-tested. Some orthopedic surgeons refused to implant these two devices in their patients due to poor testing that caused a higher revision rate. In addition, medical implants are usually sold with warranties, but not DePuy’s. Patients found that DePuy did not place warranties on its products, recipients must pay the full cost all over again.
New medical devices and prescription drugs typically must be approved by the U.S. Food and Drug Administration. They have to be safe for consumer use by first undergoing clinical studies and medial reviews. The F.D.A. stated in a warning letter to DePuy Orthopaedics, Inc. that, “The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch™ Personalized Solutions System and the Corail® Hip System in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act)”. (Public Health Service, 2010)
DePuy was ordered to stop selling two of its unapproved devices and also provide information needed to review another product that DePuy had been selling even though it was never approved, which is the TruMatch Personalized Solution System that is used to produce custom surgical guides to help a surgeon position a knee implant.
According to company spokeswoman Lorie Gawreluk, the acetabular system, launched in 2004, has been sold worldwide. The resurfacing system, introduced in 2003, is only sold outside the U.S. Some patients in the U.S. have gotten the implants through a clinical trial, also people who have traveled outside of the U.S. for hip resurfacing or hip replacement procedures may have been fitted with ASR components.
Although, these two products of DuPuy failed to meet J&J’s criteria that stated in its credo that, “…everything we do must be of high quality”. J&J and DePuy were responsible for the failure and responded just as the Credo detailed, “…and mistakes paid for.”, rectifying the situation by providing patients and surgeons with the information and support they need, including monitoring of how well a patient's hip is working and paying for any corrective surgery. In addition, David Floyd, president of DePuy Ordopaetics, Inc., said in a statement that the recall would be a concern for patients and their family members and for surgeons.
“DePuy intends to cover reasonable and customary costs of testing and treatment for patients who need services, including revision surgery, associated with the ASR recall. DePuy will also pay for reasonable expenses related to receiving care, such as lost wages and travel costs. In order to facilitate the claims and reimbursement process and to address the questions and concerns of ASR patients, DePuy has set up 34 call centers worldwide. To support the needs of surgeons, DePuy has hosted webcasts and distributed informational materials”. (DuPuy Companies, 2010)
After all, DePuy appeared to be very responsible for the failures. The company committed to its responsibility by assisting patients and healthcare providers by providing information through multiple channels, such as website DePuy Recall; http://www.depuy-recall.org, andASR Help Line for answers to questions and to initiate claims for reimbursement, and fianlly announced a voluntary recall of the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System in August 2010, approximately 93,000 of ASR patients worldwide. Moreover, on March 4, 2011, David Floyd, the president of DePuy Ordopaetics, Inc. resigned. There is no longer use of these two artificial hip joints as of the August recall, but DePuy stated that it will keep working on developing a new generation of both products. The Johnson & Johnson Family of Companies and DePuy Ordopaetics, Inc.will have to build and bring back the customer trust and the corporate image. They have to learn from this recall, also the recalls that have occurred in the past to ensure that their products are safe for customers.
The complaints about defective hip implants made by DePuy Orthopaedics, Inc., a part of Johnson and Johnson’s Medical Devices & Diagnostics group, had been sending to the U.S. Food and Drug Administration over the past two years. On August 24, 2010, after a warning letter from the F.D.A. and the new medical information of these faulty hip implants from the UK National Joint Registry, DePuy finally recalled about 93,000 of these artificial joints. What are the ethical risks and consequences associated with DePuy’s products? What should DePuy do to correct these failures?
DePuy Inc., a member of the Johnson & Johnson Family of Companies, a world leader in health care products and services, was founded in 1895. DePuy Inc. develops and markets products under the DePuy Orthopaedics, Inc.; DePuy Spine, Inc.; Codman & Shurtleff, Inc.; and DePuy Mitek units.
DePuy Orthopaedics Inc. was the first commercial orthopaedics company in the U.S. To become a global leader in orthopaedic devices and supplies, the company has committed to the innovation in patient care and improvement of movement in patients’ lives …show more content…
around the world. DePuy Orthopaedics manufactures more than 200 of joint replacement products that include hip, knee, ankle, finger and shoulder, and operating room products. DePuy Orthopaedics, Inc. and its medical devices & diagnostics group have been developing their technologies, products and services, and addressing some of the most chronic and pervasive conditions, and continuing in their tradition of advancing the standard of healthcare and education, and new treatments and solutions. However, on August 24, 2010, DePuy Orthopaedics and J&J announced recall of two of DePuy hip replacement products, the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System. The DePuy ASR™ Hip Resurfacing System, a rounded bone atop the thigh bone that fits into that socket like a ball, was available outside the U.S. and the ASR™ XL Acetabular System, a hip socket used in traditional hip replacement, was available worldwide.
“The ASR Hip System was designed as an additional option for surgeons in treating patients suffering from severe and disabling arthritis and other diseases of the hip joint. The ASR Hip System was designed and developed in conjunction with experienced orthopaedic surgeons and leaders in the biomedical field. The ASR Hip System was cleared for marketing by the U.S. Food and Drug Administration under the 510k regulatory process established by Congress, which is used for a majority of medical devices on the market. The ASR Hip Resurfacing System was introduced outside the US in 2003. The ASR XL Acetabular System was introduced outside the US in 2004 and in the US in 2005”. (DePuy Companies, 2010)
The DePuy hip replacement recall had begun after the UK National Joint Registry, indicated the high early failure rate of both the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Moreover, the U.S. Food and Drug Administration had been receiving complaints about the failures of these two hip devices over the last few years, even though, the company stated that the majority of hip replacements using the ASR devices had been successful. On average, most hip replacements last for 10 to 20 years depends on the persons and type of activity they do. However, the F.D.A. records show that approximately12 percent of patients who received the DePuy ASR Hip Resurfacing system and 13 percent of patients who received the ASR XL Acetabular System needed a second hip replacement within five years of receiving the ASR implants. In other words, one out of every eight hip replacements with this implant system would fail, often requiring a revision surgery.
“We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality”. (Johnson & Johnson Services, Inc., 1997-2011)
J&J stated in its credo that the organization will provide the high quality of products and services to the customer.
This culture is followed still today to achieve the commitments stated in the Credo. However, the growing number of operating companies continues to grow and put strain on J&J, a parent company. As in this case, defective and unsafe hip implants made by Depuy Ordopaetics, units of J&J, caused problems in patients who used these products. Both two types of Depuy hip implant didn’t have a sufficient screw or cement to be able to hold on to the socket itself, causing dislocation between the two parts of artificial hip joint that move against each other. Patients usually experienced severe pain and swelling and had difficulty walking or inability to walk. These problems were quickly identified through surgery and
x-rays.
Nevertheless, another problem associated with artificial joint had also occurred in some patients. In fact, they are part of a category of implants called metal-on-metal bearings that often degrade and loosen prematurely, which can generate debris from wear, causing flakes of metal to leach into the bloodstream, also inflammation and tissue damage in certain patients. The movement when the metal parts of the implant rubbed against each other caused metal poisoning and a spectrum of health problems ranging from mild to debilitating. The toxic heavy metals known as cobalt and chromium were frequently released into the bloodstream and could destroy the bone and issue surrounding the implant, a condition known as metallosis , and that when the device failed and patient needed a second hip replacement procedure.
So many people had questioned that if these devices have been tested or were well-tested. Some orthopedic surgeons refused to implant these two devices in their patients due to poor testing that caused a higher revision rate. In addition, medical implants are usually sold with warranties, but not DePuy’s. Patients found that DePuy did not place warranties on its products, recipients must pay the full cost all over again.
New medical devices and prescription drugs typically must be approved by the U.S. Food and Drug Administration. They have to be safe for consumer use by first undergoing clinical studies and medial reviews. The F.D.A. stated in a warning letter to DePuy Orthopaedics, Inc. that, “The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch™ Personalized Solutions System and the Corail® Hip System in the United States (U.S.) without the required marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act)”. (Public Health Service, 2010)
DePuy was ordered to stop selling two of its unapproved devices and also provide information needed to review another product that DePuy had been selling even though it was never approved, which is the TruMatch Personalized Solution System that is used to produce custom surgical guides to help a surgeon position a knee implant.
According to company spokeswoman Lorie Gawreluk, the acetabular system, launched in 2004, has been sold worldwide. The resurfacing system, introduced in 2003, is only sold outside the U.S. Some patients in the U.S. have gotten the implants through a clinical trial, also people who have traveled outside of the U.S. for hip resurfacing or hip replacement procedures may have been fitted with ASR components.
Although, these two products of DuPuy failed to meet J&J’s criteria that stated in its credo that, “…everything we do must be of high quality”. J&J and DePuy were responsible for the failure and responded just as the Credo detailed, “…and mistakes paid for.”, rectifying the situation by providing patients and surgeons with the information and support they need, including monitoring of how well a patient's hip is working and paying for any corrective surgery. In addition, David Floyd, president of DePuy Ordopaetics, Inc., said in a statement that the recall would be a concern for patients and their family members and for surgeons.
“DePuy intends to cover reasonable and customary costs of testing and treatment for patients who need services, including revision surgery, associated with the ASR recall. DePuy will also pay for reasonable expenses related to receiving care, such as lost wages and travel costs. In order to facilitate the claims and reimbursement process and to address the questions and concerns of ASR patients, DePuy has set up 34 call centers worldwide. To support the needs of surgeons, DePuy has hosted webcasts and distributed informational materials”. (DuPuy Companies, 2010)
After all, DePuy appeared to be very responsible for the failures. The company committed to its responsibility by assisting patients and healthcare providers by providing information through multiple channels, such as website DePuy Recall; http://www.depuy-recall.org, andASR Help Line for answers to questions and to initiate claims for reimbursement, and fianlly announced a voluntary recall of the ASR™ XL Acetabular System and the DePuy ASR™ Hip Resurfacing System in August 2010, approximately 93,000 of ASR patients worldwide. Moreover, on March 4, 2011, David Floyd, the president of DePuy Ordopaetics, Inc. resigned. There is no longer use of these two artificial hip joints as of the August recall, but DePuy stated that it will keep working on developing a new generation of both products. The Johnson & Johnson Family of Companies and DePuy Ordopaetics, Inc.will have to build and bring back the customer trust and the corporate image. They have to learn from this recall, also the recalls that have occurred in the past to ensure that their products are safe for customers.