OPTIPAC 40 REFOB BONE CMT R-3

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, APPROXIMATELY 3 YEARS POST IMPLANTATION, PATIENT HAD DEVELOPED PAIN IN THE RIGHT KNEE, AND SAID THE KNEE NEVER FELT QUITE RIGHT. APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT DESCRIBED ANTERIOR KNEE PAIN ALONG WITH INSTABILITY. THE GENERAL PROVIDER INCREASED PATIENT'S PAIN MEDICATION AND REFERRED TO MUSCULAR SKELETAL CLINIC. APPROXIMATELY 6 YEARS POST IMPLANTATION, RADIOLOGICAL INVESTIGATIONS CONFIRMED LOOSENING OF THE TIBIAL COMPONENT. THE PATIENT WAS SUBSEQUENTLY REVISED. 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 NUMBER#: 00598604701, ITEM NAME#: STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 5 FOR CEMENTED USE ONLY, LOT#: 64129614. ITEM NUMBER#: 00596601702, ITEM NAME#: CRUCIATE RETAINING (CR) FEMORAL COMPONENT OPTION SIZE G RIGHT FOR CEMENTED USE ONLY, LOT#: 63701739. ITEM NUMBER#: 90597004012, ITEM NAME#: ARTICULAR SURFACE, LOT 64242383. ITEM NUMBER#: 4711500396-3, ITEM NAME#: OPTIPAC 60 REFOB BONE CMT R-3, LOT#: 836BA01425. ITEM NUMBER#: 00625006520, ITEM NAME#: BONE SCREW SELF TAPPING 6.5 MM DIA. 20 MM LENGTH, LOT#: 64106453. ITEM NUMBER#: 00625006520, ITEM NAME#: BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH, LOT#: 64102119. G2 ¿ FOREIGN ¿ EUROPE: 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.