Johnson & Johnson, in conjunction with its DePuy Orthopaedics subsidiary, has recalled parts used for hip replacements. At issue is the high rate of repeat surgeries needed by people who have received the parts. An estimated 93,000 people will be affected by Johnson & Johnson’s latest product recall.
Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System, which is the cup portion of a replacement hip joint, and the DePuy ASR Hip Resurfacing System. Resurfacing involves implanting a cup and capping the ball at the top of the thighbone in a procedure that preserves more bone than traditional replacements. It is geared toward younger patients.
Although this recall is voluntary, DePuy also received a warning letter from the FDA that charges the company with marketing some other joint replacement products without required approval. Physicians were notified about potential problems with the hip replacement parts beginning in March of this year. The decision to recall the parts was made when the results of a new study confirmed a five-year rate of revision surgery of about 12% for the ASR resurfacing system and about 13% for the ASR XL system, according to DePuy, which is higher than the expected rate.
Patients who reported problems in the first five years and had revision surgery reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently. These symptoms may indicate serious problems, including:
Loosening – when the implant does not stay attached to the bone in the correct position
Fracture – where the bone around the implant may have broken
Dislocation – where the two parts of the implant that move against each other are no longer aligned
Any person who has had a hip replacement should contact their orthopaedic surgeon to determine whether they received a DePuy ASR hip implant. If a person doesn’t know who performed their hip replacement surgery, they should ask their primary care physician or the hospital where the surgery took place to help them find out.
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