Johnson and Johnson has recalled 2 Hip Implants because of failure. The two implants were made by the DePuy Orthopaedics unit of Johnson & Johnson. The decision to withdrawn the products was based upon the fact that many patients require a second hip replacement because of product failure.
DePuy release a
statement today that they two products being recalled were: the ASR XL Acetabular System, a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur, a method intended to preserve more bone.
There about 93,000 of the defective appliances that have been implanted worldwide.
For over two years the US Food and Drug Administration (FDA) has been besieged with complaints about the failure of the devices and painful surgery to replace them.
The office of
Jon L. Gelman has
advocated for consumer rights and has helped those who have unfortunately received defective medical devices. Please call 1-973-696-7900 or e-mail
jon@gelmans.com for further information.
Depuy ASR XL Hip Replacement -- Recalled Device Case Criteria
1. Patients who received the DePuy ASR XL hip replacement device between the years 2005 and 2010.
2. Following the hip replacement surgery, the patient experienced any of the following symptoms:
A. Problems with walking, pain, swelling or discomfort in the hip area.
B. Loosening in the hip joint – where the implant fails to stay attached to the bone in the correct position.
C. Fracture - where the bone around the implant may have broken.
D. Dislocation – where the two parts of the implant that move against one another became misaligned.
E. Clicking, popping or grinding in the area of the hip implant.
F. Metal debris – where metal particles from the component parts moving together spread around the hip area. (flecks of metal shavings, known as metal ions, are released into the area surrounding the implant, destroying bone and soft tissue).
G. Device failure from loosening due to bone loss.
H. Blood test results where high levels of chromium and cobalt are found (caused by metal debris).
I. Any of the above symptoms or related conditions that result in revision surgery to remove the defective DePuy ASR XL hip device.
3. Patients who were implanted with the recalled DePuy ASR XL device may have recently received a notice of recall letter from their treating orthopedic surgeon, DePuy Orthopaedics, Inc., or DePuy’s parent company, Johnson & Johnson.