REFOBACIN BONE CEMENT R 2X40G

Additional Manufacturer Narrative

(B)(4). B3 : EVENT DATE : JULY 2022. D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D6B: JULY 2022. D10: (B)(6) - FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT - LOT 63487609. (B)(6) - ARTICULAR SURFACE SIZE EF 10 MM HEIGHT ''USE WITH PLATE 5 - LOT 63459803. (B)(6) - STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 5 FOR CEMENTED USE ONLY - LOT 63314083. (B)(6) - ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS - LOT 63426272. G2: FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. G-4: 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.

Description of Event or Problem

IT WAS REPORTED BY PATIENTS¿ LEGAL COUNSEL THAT THE PATIENT UNDERWENT A LEFT INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT HAD BEEN EXPERIENCING POST-OP PAIN AND MOBILITY ISSUES NOTING THAT WAS UNABLE TO NOT WALK. A CT SCAN REVEALED THAT THE KNEE REPLACEMENT WAS DEFECTIVE AND THE PATIENT WAS SUBSEQUENTLY REVISED SIX YEARS LATER. THE ORIGINAL SYSTEM WAS REMOVED AND A NEW ONE WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.