The Food and Drug Administration (FDA) in America continues to monitor drugs and medical treatment options on a routine basis to ensure the safety of the American people. Sometimes, it also issues public health notices and advisories on options which have been deemed unsafe by medical research. In cases like these, the FDA may issue a notice to the manufacturers of the drug or product, ordering them to recall the product from the market. It is the responsibility of the manufacturer to carry out rigorous testing and raise the safety standards of their product. In some scenarios, the manufacturer may decide to voluntarily recall its product in light of new research which brings to surface a hazard. While the FDA is primarily concerned with drugs and medicines, they also look into surgical implants and products like hip replacement options.
DePuy Orthopedics is a company which has been manufacturing orthopedic products since 1895, with a primary focus on products used in reconstruction of damaged joints. In 1998, the company was acquired by Johnson and Johnson, a top-ranking Fortune 500 multinational company dealing in medicinal equipment and consumer goods. Despite its excellent worldwide reputation, the company has recently become involved in a recall incident concerning one of the products made by DePuy.
The DePuy hip recall notice was issued in 2010 and ordered the recall of two particular products, the DePuy ASR (Articular Surface Replacement) Hip Resurfacing System and the ASR XL Acetabular System. Both of these products are complete metal replacements for a faulty hip bone. A metal cap is attached to the thigh bone of the individual, and the socket of the pelvis is replaced with a metallic cup to restore regular movement. This surgical procedure became highly popular among the elderly who experienced a weakening of the bones and problems with mobility.
However, many individuals began to complain of increased pain and a lack of flexibility soon after undergoing the operation. Some individuals also experienced metal poisoning due to the friction between the two components. In 2010 information from the National Joint Registry in England and Wales showed that the DePuy products were faulty and required individuals to undergo multiple revision surgeries. The organization carried out post-market testing over an 8 year period and concluded that 1 in 8 people who used DePuy’s products required revision surgery within 5 years. In response, the company issued a DePuy hip recall, to improve the safety of the product before re-release.
DePuy hip recall
By the year 2010, roughly 93,000 people across the world had undergone a hip replacement surgery involving DePuy’s products. When the company issued a voluntary recall, it was taken as a universal admission of guilt on a faulty product. Individuals who had experienced physical and emotional pain as a result of the surgery began to file lawsuits against DePuy, many of which are still being fought in court. While the company has been affected financially, it is expected that the next products will be safer and more effective.
DePuy Orthopedics is a company which has been manufacturing orthopedic products since 1895, with a primary focus on products used in reconstruction of damaged joints. In 1998, the company was acquired by Johnson and Johnson, a top-ranking Fortune 500 multinational company dealing in medicinal equipment and consumer goods. Despite its excellent worldwide reputation, the company has recently become involved in a recall incident concerning one of the products made by DePuy.
The DePuy hip recall notice was issued in 2010 and ordered the recall of two particular products, the DePuy ASR (Articular Surface Replacement) Hip Resurfacing System and the ASR XL Acetabular System. Both of these products are complete metal replacements for a faulty hip bone. A metal cap is attached to the thigh bone of the individual, and the socket of the pelvis is replaced with a metallic cup to restore regular movement. This surgical procedure became highly popular among the elderly who experienced a weakening of the bones and problems with mobility.
However, many individuals began to complain of increased pain and a lack of flexibility soon after undergoing the operation. Some individuals also experienced metal poisoning due to the friction between the two components. In 2010 information from the National Joint Registry in England and Wales showed that the DePuy products were faulty and required individuals to undergo multiple revision surgeries. The organization carried out post-market testing over an 8 year period and concluded that 1 in 8 people who used DePuy’s products required revision surgery within 5 years. In response, the company issued a DePuy hip recall, to improve the safety of the product before re-release.
DePuy hip recall
By the year 2010, roughly 93,000 people across the world had undergone a hip replacement surgery involving DePuy’s products. When the company issued a voluntary recall, it was taken as a universal admission of guilt on a faulty product. Individuals who had experienced physical and emotional pain as a result of the surgery began to file lawsuits against DePuy, many of which are still being fought in court. While the company has been affected financially, it is expected that the next products will be safer and more effective.