High Rate of Failure was the main reason why DePuy Hip Implant systems were recalled. A study indicated that the five year failure of this product was approximately 13 % or 1 in 8 patients. The survey that was carried out by an independent national registry based in UK which is responsible for tracking implant performances and outcomes concluded that more patients with ASR Hip System implants than previously reported to DePuy had undergone revision surgery. In these revision surgeries, the existing hip implant was removed and was replaced with the new hip implant.
In ASR XL Total Hip Replacement a one piece metal component called acetabular cup was placed in the acetabulum. The femoral head was replaced with a metal ball that was connected to a metal stem placed inside the femur. The acetabular cup rested on and moved directly against the femoral head. This resulted in two metal parts rubbing against each other and producing friction. This friction allowed chromium and cobalt ions to escape and disperse to nearby parts of the body, in turn leading to elevated levels of cobalt and chromium ions in the bloodstream. These relocated ions also infiltrated the organs, produced local irritation, and even created cysts. Many cases were reported where doctors had to break open and leak the contents of these kinds of cysts while performing revision surgeries.
Now the potential problems posed related to this implants were:
- Component loosening or Component misalignments- typically in this case cup portions of ASR Hip Replacements were too loose, failing to secure itself against and within the bone growth.
- Fracture or dislocation of bones
- Metal sensitivity and pain- especially at the site of hip replacement
- Increased levels of metal ions in blood- or heavy metal toxicity in the bloodstream
- Bone staining
- Necrosis or premature death of cells
- Damage of nerves, tissues or muscles.
The problems worsened when it was diagnosed that even after a second or revision surgery, where the defective device was replaced there were chances that the possibly dangerous and dead fragments were still left in the body to be discovered years later.
FDA started getting problems by 2008, and it was only in March 2010 that the Johnson and Johnson admitted that ASR products had a higher than normal failure rate. In August 2010, a total voluntary recall of both ASR products was issued by DePuy. Initially the recall was dramatized as a phase out of the ASR Hip implant by the DePuy Orthopedics owing to declining sales. However, when similar kind of health problems were also reported in Australia followed by a recall of the implants by Australian National Joint Replacement Registry, it was quite evident that the DePuy ASR products had failed miserably.
Various individual lawsuits with at least one class action lawsuit have been filed against DePuy Hip Replacements. The lawsuits mainly alleged that the manufacturers in spite of being aware of the problems that the implants could cause turned a blind eye towards them and carried on making the defective products. Not only this, even after being well aware of the disastrous effects that the implants caused, it delayed the recall thereby adding to the sufferings and pain.