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

Additional Manufacturer Narrative

COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. ADDITIONAL CODES HRS, HWC. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022. PATIENT HAS BOTH LEFT PROSTHETIC DISTAL FEMUR NONUNION; WAS TREATED WITH A VARIABLE ANGLE (VA) CONDYLAR PLATE. THERE WERE EIGHT LOCKING SCREWS, TWO CORTICAL SCREWS AND A PLATE. THE PLATE, ALL THE SCREWS, AND THE TOTAL BROKEN PARTS WERE REMOVED SUCCESSFULLY. THE PATIENT HAD TO STAY FOR THE SURGEON TO PERFORM A DISTAL FEMORAL REPLACEMENT. THIS COMPLAINT IS FOR A 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/12 HOLE/266MM/LEFT. THIS IS REPORT 1 OF 11 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. H10: ADDITIONAL NARRATIVE: B7 H3, H4, H6: PART 04.124.413, LOT 60P5120: MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: JULY 13, 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT STERILE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WAS NO DAMAGE OR DEFECTS WITH THE DEVICE. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE COMPLEX GEOMETRY OF THE DEVICE. THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WAS FOUND TO HAVE NO DAMAGE OR DEFECTS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 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.