The Food and Drug Administration has recalled 31,936 hip replacement systems made by Smith & Nephew because of the “higher than anticipated complaint and adverse event trend.”
This follows the FDA’s Class 2 recall of the company’s Tandem Bipolar hip on November 3, 2016, because “some Bipolar shells were manufactured with an out-of-specification retainer groove.”
Three new Class 2 recall, dated January 4, 2017, covers Smith & Nephew hip systems distributed worldwide:
- 6,266 units of the Modular Redapt Hip Systems. It received FDA 510(k) premarket approval on October 15, 2012.
- 11,999 units of the Modular SMF Hip System. It received FDA 510(k) approval on July 31, 2008.
- 13,671 units of Modular Necks. It received FDA 510(k) approval on January 10, 2008.
The FDA grants clearance to market a medical device under the 510(k) shortcut if it is substantially equivalent to a pre-existing, approved device. A Class 2 recall is a situation in which use of a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Smith & Nephew is a UK company with an office in Memphis, TN. As hip litigation builds against the company, the Judical Panel on Multidistrict Litigation (JPMDL) is considering the creation of MDL No. 2775 for Smith & Nephew Hip Implant Products Liability Litigation. Eight plaintiffs who had the Birmingham Hip Resurfacing (“BHR”) and R3 metal-on-metal liner (“R3”) implanted filed the motion.
The devices were approved by the FDA in 2006, but Smith & Nephew recalled the R3 in June 2012 and withdrew the BHR device in June 2015 due to similar high failure rates. Data shows that the devices have a 10-year revision rate of 14.5 percent.
There are 31 cases involving the BHR and R3 devices pending in 22 different districts, with 32 different law firms involved. Plaintiff’s attorneys Jasper D. Ward IV and Alex C. Davis of Jones Ward in Louisville, KY, requested the cases be consolidated in the US District Court of Maryland.
The JPMDL previously created MDLs involving six other metal-on-metal hips:
- MDL 2158, In re: Zimmer Durom Hip Cup Products Liability Litigation
- MDL 2197, In Re: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation
- MDL 2144, In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation
- MDL 2329, In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation
- MDL 2391, In re: Biomet M2a Magnum Hip Implant Products Liability Litigation
- MDL 2441, In re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation.
There are 719,000 total knee replacements and 332,000 hip replacements performed annually in the U.S. (data from the Centers for Disease Control and Prevention (CDC). This number will grow exponentially with a more active and aging population.)
- More than 7 million people in the U.S. have had a knee or hip replacement surgery
- Hip and knee devices account for more than 85% of the joint reconstruction and replacement market
- Joint registries demonstrate up to a 50% reduction in revision rates after registry initiation and identification of best practices