DePuy Orthopaedics' hip replacement devices are separated into two series: the ASR 100 and the ASR 300. There are 15 kinds of acetabular implants that fall under the ASR 100 series and they range in sizes from 44-70mm. The other 14 implants still have the same diameters but are classified under the ASR 300 series. In October of this year, the U.S. Food and Drugs Administration have issued an enforcement report based on the status of the DePuy hip replacement recall. At the time of the report, 36, 486 units were still sold on the market.
In the FDA's report, it said:
“As part of the post-market surveillance, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-market surveillance activities, the firm recently received and analyzed new data regarding the ASR platform which suggests a higher than expected revision rate for the ASR XL Monoblock Metal-on-Metal (MoM) System linked to usage of monoblock MoM cups with corresponding head sizes below 50mm in diameter. As a result of the findings, DePuy Orthopaedics issued a Field Safety Notice to share the new data with the surgeons and reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorship.”
That being said, smaller hip replacement devices are found out to have a higher failure rate than larger ones. It would be a safe assumption that majority of those needing revision surgery are recipients of smaller types of the ASRs. Lawsuits with plaintiffs who have the said prostheses are then more likely to have a favorable outcome.
However, larger cups aren't let off that easily either. “Reasons for revision are typical for the class of large diameter MoM monoblock cups and includes component loosening, component malalignment, infection, pain, fracture, dislocation and metal sensitivity,” states the FDA.
Whatever the case may be, recipients who have had to undergo revision surgery or is experiencing a vast amount of trouble caused by the defective implant should seek the expertise of a lawyer and find out more about the ongoing DePuy lawsuit.
Outcome Of DePuy Lawsuit May Be Determined By Type Of DePuy Cupprof.
Posted in depuylawsuit's blog 2010-12-09


