Unfortunately, yet another prosthetic device has been recalled due to unexpectedly high complication rates. On August 24, 2010, DePuy Orthopaedics Inc., a Johnson & Johnson company, voluntarily recalled its hip replacement product, the ASR TM XL Acetabular System.
DePuy claimed the recall was prompted by data it received in 2010 from the National Joint Registry of England and Wales. This study demonstrated that approximately 13% (or 1 in 8 patients) receiving this particular prosthesis required revision surgery. This revision rate far exceeds the <1% revision rate experienced with similar devices. While the reasons for this unusually high revision rate are still under investigation, DePuy has conceded that a significant percentage of the patients requiring revisions have experienced a reaction to the prosthesis' metal. When the metal pieces rub together, tiny particles of metal can enter the bloodstream setting off, in some patients, a severe allergic reaction. If this occurs, treatment is critical. Without appropriate treatment, a patient's condition can deteriorate and the joint can be severely damaged.
Although patients experiencing a reaction to metal can experience severe pain, a physician should evaluate you to determine whether you require testing of the metal levels in your blood. The testing can indicate whether the concentration of metal particles is accumulating in the patient's blood and thus increasing the patient's risk for a severe reaction.
In addition to the reactions some patients have had to the metal, there are concerns about the implant's design. Specifically, the cup may too shallow to adequately promote bone growth. This poses a problem since the ASR TM is implanted without cement or other fixation. Without adequate bone growth, the hip implant will likely fail. As with all medical issues, it is critical to first consult with your doctor and receive appropriate health care.
If your surgeon has advised you that your DePuy ASR Hip needs to be removed, you should consult with an attorney to be advised of your legal rights and options.
Call DePuy Hip Replacement Recall Attorneys at 1-888-633-0360
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