Overview: Johnson & Johnson has recalled 7,500 Adept hip implants after data from Britain and Australia indicated a high failure rate, reports the Daily News. The hip implant, which was sold outside of the United States, reportedly caused complications such as pain and difficulty walking in an unacceptably high number of patients, forcing them to undergo revision surgery to remove the device. This is the second time that Johnson & Johnson has had to recall a metal-on-metal hip implant since 2010, when 93,000 ASR hips were recalled due to a high revision rate. The recall comes at a time when J&J is actively involved in litigation over the all-metal hips, and raises questions about the safety of all-metal hip implants as a class of medical devices.
- J&J’s DePuy unit has recalled 7,500 Adept hip implants in 21 countries outside of the United States; the recall affects the modular head component
- British data shows that the implant fails in 12 percent of patients within seven years; Australian data indicates a failure rate of 7 percent in three years
- This is J&J’s second metal hip implant recall in 2 and a half years; litigation is currently underway for the DePuy ASR, which was recalled in 2010 due to a high failure rate
Product: Adept modular head
Manufacturer: DePuy Orthopaedics/ Johnson & Johnson
Side Effects & Complications
- High failure rate
- Necrosis (tissue death)
- Increased levels of cobalt and chromium ions
- Pain at the implant, sometimes spreading to the groin and back
- Osteolysis (bone loss)
- Fluid collections/solid masses around the hip joint
Adept Head Recalled Due to High Revision Rates
Johnson & Johnson’s DePuy unit recalled 7,500 Adept hip implant modular heads sold in 21 different countries outside of the United States between 2004 and 2011. The recall concerns the head or ball placed atop the femoral stem that rotates within the cup, or hip socket component of the metal-on-metal device. The Daily News reports that the recall was issued due to reports of pain, difficulty walking and other complications leading a high rate of early failure. J&J said that it notified surgeons about the problem on January 14th, after data from a UK registry found a failure rate of 12 percent in seven years and an Australian registry suggested a failure rate of 7 percent in three years.
DePuy ASR Recall and Metal-on-Metal Hip Implants
This is the second time Johnson & Johnson has had to recall an all-metal hip implant since 2010, when 93,000 ASR hip implants were recalled. As with the Adept, the recall was based on an unacceptably high rate of failure. In fact, the ASR recall is now known as one of the biggest medical device failures in decades; at the time of the recall, the company said the hips failed at a rate of 12 percent in five years, but more recent data shows that the failure rate is much higher.
Litigation is currently underway for the DePuy ASR. The first lawsuit has gone to trial in Los Angeles state court in the case of Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County. Loren Kransky’s lawsuit is one of 10,000 in the United States alleging injuries and serious complications from the DePuy ASR.