4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT

Description of Event or Problem

DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT SUSTAINED PERIPROSTHETIC FRACTURE (PPF) BELOW FEMORAL NAIL IN (B)(6) AND WAS FIXED WITH VA CONDYLAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2022. PATIENT WAS READMITTED APPROXIMATELY 3 MONTHS AFTER IMPLANT WITH PLATE FRACTURE. NO NEW TRAUMA. HAD BEEN MOBILIZING IN RESIDENTIAL HOME. NORMAL TO LOW BMI. FRACTURE NON-UNITED, BUT NO EVIDENCE OF INFECTION. REVISION OCCURRED (B)(6) 2022. THIS IS REPORT 1 OF 11 FOR (B)(4). THIS REPORT IS FOR A VA-LCP CONDYLAR PLATE. THIS COMPLAINT IS LINKED TO (B)(4).

Additional Manufacturer Narrative

IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. UNKNOWN BETWEEN MARCH 2022 AND JUNE 2022. IMPLANT DATE UNKNOWN DATE IN MARCH 2022. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. INVESTIGATION SUMMARY: THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE FROM ATTACHMENT. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2 HAD BROKEN AT THE MIDDLE SHAFT SECTION. X-RAY EVIDENCE PROVIDED SHOWS A PLATE AND SCREW CONSTRUCT AT THE LEFT DISTAL FEMUR WITH SIGNS OF BONE AND PLATE BREAKAGE. NO OTHER ISSUES WERE IDENTIFIED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE VA-LCP CONDYLAR PLATE 4.5/5.0 LE 12HO L2. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY: PRODUCT CODE: 02.124.413S, LOT NUMBER: 374P884, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 05 OCT 2021, EXPIRATION DATE: 01 SEPT 2031. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.