The premature failure of the hip replacement devices manufactured by DePuy led to hundreds of recipients clamoring for justice. Globally, 93,000 units of the ASR XL Acetabular System and the ASR Hip Resurfacing System were withdrawn. One out of eight device recipients require another surgery to correct the damage done.
An enforcement report that divides the hip replacement devices into two series was issued by the United States Food and Drugs Administration in its effort to scrutinize DePuy’s post-market status. One series, the ASR 100 have 15 types of hip devices under it which have cup dimensions of 44mm to 70mm. On the other hand, the remaining 14 of these implants are categorized under the ASR 300 all of which have the same cup diameter range as the ASR 100.
To give description to the recall, the FDA had this to say:
“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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.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.”
The report suggests that hip replacement devices which have cup diameters below 50mm are more at risk of needing to be replaced. It is then safe to assume that women, who are significantly smaller than most men, are the recipients of these kinds of hip devices and that they are probable candiates of the second hip replacement procedure. Overall, the likelihood for both hip replacement implants to be corrected is roughly 12 percent within five years.
ASR devices with larger cup sizes are liable to be revised no more frequently than other implants. The report have been known as saying:
“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.”
The report did not contain any reference to metallosis or cobalt and chromium poisoning brought on by the device’s components. Studies have indicated that this type of poisoning can cause severe damage if the source is not removed.
You can always visit the DePuy hip lawsuit site to be know about up-to-date information regarding the case. A lawyer can evaluate your case once you are sure on the exact type of ASR device you are implanted with.
Tags: Womens World