Recently, at the end of August 2010, Johnson & Johnson, along with its DePuy Orthopaedics subsidiary, announced that it is recalling parts used in hip replacements. The recall includes the DePuy ASR XL Acetabular System – the cup portion of a replacement hip joint – and the DePuy ASR Hip Resurfacing System. There are an estimated 93,000 people that have the defective hardware. The recall came on the heels of the National Joint Registry of England and Wales report, which found that one eighth of all patients with the ASR hip replacement had to suffer repeated surgery to make adjustments to the device within five years of receiving the implant. Many patients have had multiple surgeries and severe complications; now we know why.
Anyone that has had a hip replacement can tell you that a hip replacement is a major ordeal. Indeed, the studies have shown that getting a second hip replacement is much more difficult, poses increased risks of complication, and decreases the chance of a successful outcome. This creates a dilemma for anyone with a DePuy hip replacement. However, even DePuy is stating that patients with one of its hip replacements need to contact a physician and discuss all the options.
While the symptoms vary with each patient to a degree, the symptoms that indicate serious problems are as follows:
• Loosening – the implant is not saying attached to the bone in the correct position;
• Fracture – where the bone around the implant is broken;
• Dislocation – the two parts of the implant are no longer aligned;
• Debris – metal particles from the two metal pieces come loose and disburse around the hip area.
In March of this year, DePuy sent a letter to doctors stating that recently analyzed data from Australia indicated a high failure rate with the ASR hip replacements. Additionally, that same data indicated that the risk of these complications was the highest for patients of less stature, such as women and patients with weak bones.
Many orthopedic doctors believe that the metal on metal implant had a design flaw from the start, which made it very difficult to implant properly. It now seems that Johnson & Johnson/DePuy also believe there to be a flaw in the ASR hip replacements, which is no doubt the impetus for the massive recall. While Johnson & Johnson and DePuy are claiming that they are going to “make things right,” my experience from dealing with such companies is that their notions of justice are often very different than mine.