VA-LCP CONDYLAR PLATE 4.5/5.0 R 12HO L26

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT FELL ON (B)(6) 2023 WHICH CAUSED A FRACTURE OF THE FEMUR ON THE RIGHT SIDE. PATIENT UNDERWENT AN OPERATION ON (B)(6) 2023 TO IMPLANT THE PLATE. AFTER 3 MONTHS AND A HALF LYING IN THE BED, USING WHEELCHAIR WITHOUT PUTTING FEET ON THE GROUND, THE PATIENT STARTED A PROGRESSIVE REEDUCATION AND ALSO A VERY PROGRESSIVE SUPPORT, FOLLOWING X-RAYS EXAMINATION SHOWING THE CONSOLIDATION. ON (B)(6) 2024, SHE WENT TO (B)(6) FOR A WEEK, DESPITE SOME EXPLAINABLE PAIN. THE PAIN INTENSIFIED AND BECAME INTOLERABLE. IN THE MORNING ON (B)(6) 2024 THE PATIENT HAD TO CALL A PHYSICIAN AND WAS TRANSPORTED TO THE CLINIC WHERE THE RADIOLOGIST NOTICED THE RUPTURE OF THE PLATE. NO SURGEON PRESENT IN THE CLINIC COULD EXPLAIN THE RUPTURE. PATIENT PRESENTED IN THE HOSPITAL WITH PAIN, SWELLING AND FUNCTIONAL IMPOTENCE OF THE KNEE AND LEFT THIGH AFTER ARRIVAL BY PLANE IN TENERIFE, ACCORDING TO HIS REPORT. UNTIL THE INCIDENT, THE PATIENT WAS AN ACTIVE PERSON WHO DID NOT NEED HELP. THE PATIENT IS NOW STRANDED AFTER A NEW COMPLICATED SURGICAL INTERVENTION, MAYBE WITH A PARTIAL DISABILITY. ON (B)(6) 2024 THE PATIENT UNDERWENT THE EXTRACTION OF SYNTHESIS MATERIAL, MILLING AND ACRUENTATION OF THE FOCUS, ENDOMEDULLARY SYNTHESIS WITH GAMMA NAIL 3 LONG 125°/ 400 X X10 MM. THIS REPORT IS FOR A VA-LCP CONDYLAR PLATE 4.5/5.0 R 12HO L26. THIS IS REPORT 1 OF 1 FOR (B)(4).

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J EMPLOYEE. H6: PHOTO INVESTIGATION: THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT VA-LCP CONDYLAR PLATE 4.5/5.0 R 12HO L26 WAS OBSERVED BROKEN AT THE SHAFT, ACROSS TO ONE OF THE LOCKING HOLES, BOTH FRAGMENTS WERE OBSERVED IN THE EVIDENCE PROVIDED. 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 VA-LCP CONDYLAR PLATE 4.5/5.0 R 12HO L26. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. 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. H3, H4, H6: DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: PART NUMBER: 02.124.412S. LOT NUMBER: 2673P80. MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: 10 NOV 2022. EXPIRATION DATE: 01 NOV 2032. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE FINISHED LOT NUMBER, AND NO NON-CONFORMANCES 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.