PERF CON TIB BRG LRG 22X60

Additional Manufacturer Narrative

(B)(4). D11: ASSOCIATED MEDICAL PRODUCTS. REF. 177284; LOT 2007050790; DESCRIPTION MODULAR TIBIAL TRAY LARGE 76 MM CEMENTED. ADDITIONAL INFORMATION REGARDING THE INVOLVED LOTS DETECTED DURING THE DOCUMENTAL INVESTIGATION.

Description of Event or Problem

REVISION DUE TO INSTABILITY, LOOSENING OF FEMALE SCREW, OSTEOLYSIS, POLYESILE METAL DISPOSAL.

Additional Manufacturer Narrative

(B)(4). ASSOCIATED MEDICAL PRODUCTS: REF. 177284; LOT 2007060790; DESCRIPTION MODULAR TIBIAL TRAY LGE 76 MM CEMENTED. REF. 7804-07-120; LOT 2007010785; DESCRIPTION ANATOMICAL TIBIAL STEM 14X120X5MM. REF. 7806-16-150; LOT 2007030389; DESCRIPTION FEMORAL STEM 16X150MM W/SCREW . REF. 177043; LOT 05037715; DESCRIPTION PS FEMORAL COMPONENT CLOSED BOX MED LEFT 70 MM CEMENTED. (B)(6). FOREIGN REPORT SOURCE: (B)(6). THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K143192. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009610576 - 2020 - 00007 AND 0009610576 - 2020 - 00009.

Description of Event or Problem

IT WAS REPORTED BY THE (B)(6) PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2008. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION (B)(6) 2020 DUE TO INSTABILITY OF TOTAL REVISION KNEE PROSTHESIS IMPLEMENTED IN 2008 DUE TO THE BREAKING OF THE CENTRAL STABILIZATION POST OF THE SAME, WITH LOOSENING OF THE FEMALE STEM SCREW, PRESENCE OF MULTIPLE OSTEOLYSIS, POLYESILE METAL DISPOSAL. THE CENTRAL POST WAS FOUND IN THE HOLLOW POPLITEO. RECONSTRUCTION IS NEEDED WITH CONSTRAINED IMPLANT AND INCREASES OF TRABECULAR METAL GIVEN THE LOSS OF SUBSTANCE AND THE AFFECTION OF THE LIG. SIDES.