REFOBACIN BONE CEMENT R 2X40G

Description of Event or Problem

IT WAS REPORTED BY LEGAL A PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, A LEGAL CLAIM HAS BEEN MADE DUE TO PAIN AND LIMITED MOBILITY. IT WAS NOTED THAT THE SURGEON REPORTED LOOSENING VIA X-RAY. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

Additional Manufacturer Narrative

(B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304990197. D10: ITEM NAME# FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E LEFT; ITEM NUMBER# 00576401551; LOT NUMBER# 63804557. ITEM NAME# STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4 FOR CEMENTED USE ONLY; ITEM NUMBER# 00598603702; LOT NUMBER# 63673669. ITEM NAME# ARTICULAR SURFACE SIZE EF 10 MM HEIGHT "USE WITH PLATE 3; ITEM NUMBER# 00596403210; LOT NUMBER# 63794022. G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.