You may have the right to sue Smith & Nephew if you had (or are scheduled to have) revision surgery to remove the modular femoral stem and/or the modular “neck” of one of the following recalled metal-on-metal hip replacement systems:
- Smith & Nephew Modular SMF Hip System
- Smith & Nephew Modular REDAPT Hip System
These products were recalled “due to a higher than anticipated complaint and adverse event trend,” according to the recall announcements on the FDA website, which list the FDA-determined cause as “Device Design”:
- Class 2 Device Recall Modular SMF(TM)
- Class 2 Device Recall Modular REDAPT(TM) Hip System
- Class 2 Device Recall Modular Necks
These product were shipped from October 2008 through July 2016. You may have a case even if one of these products was implanted many years ago. Our lawyers will look at your medical records and gather any other information needed to determine if you have a lawsuit.
Attorneys Fred Pritzker, David Szerlag and Brendan Flaherty are our lead lawyers for these cases. They recently won $45 million for clients injured by a product made by another manufacturer and have helped dozens of people harmed by hip implant products get compensation.
MAUDE Adverse Event Reports Shed Light on Revision Surgery Causes
At lease some of the complaints referenced in the recall announcements are available to the public on the MAUDE database, which houses medical device reports submitted to the FDA by manufacturers, importers, health care professionals and patients.
An analysis of the adverse events reported to the FDA (on the MAUDE database) found the following reported issues related to revision surgery after implantation of the Modular SMF or Modular REDAPT (please note that these are reports and have not been proven as facts):
- pain, with a couple of the reports specifically mentioning the thigh;
- loosening, with the femoral stem being specifically mentioned;
- corrosion, with some of the reports specifically mentioning the femoral stem, neck/stem joint, and trunnionosis;
- high metal ion levels (metallosis, a reaction to the metal debris), specifically cobalt and chromium, with one report stating that chromium was “in the blood”;
- aseptic, lymphocyte-dominated vasculitis-associated lesion (ALVAL), which can cause pain and lead to pseudotumors;
- activity limiting.
The pain, loosening, corrosion, and other problems are most likely the result of the body’s reaction to the elevated metal ion levels because chromium and cobalt can kill tissue (called necrosis) and are thought to cause the pseudo-tumors (Wiley). Metallosis has been a problem with many other metal-on-metal hip replacement products made by other manufacturers.
Anyone can go to the MAUDE search page and look up adverse event reports with the name of a manufacturer or brand, product number, product code or report number. We feel that this is important information for every patient to know.
Get Legal Help
Our law firm has obtained large settlements for numerous clients in cases involving revision surgery to remove metal-on-metal hip replacement products. This experience can be used to help you get the compensation you deserve. You can use our free consultation form to contact attorneys Fred Pritzker, David Szerlag and Brendan Flaherty.
Resource: Wiley KF, Ding K, Stoner JA, Teague DC, Yousuf KM. “Incidence of pseudotumor and acute lymphocytic vasculitis associated lesion (ALVAL) reactions in metal-on-metal hip articulations: a meta-analysis. J Arthroplasty.” 2013 Aug; 28(7):1238-45.