4.5 VA-LCP CURVED COND PL/8 HOLE/195/RT

Additional Manufacturer Narrative

PRODUCT COMPLAINT (B)(4). 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. A PHOTO INVESTIGATION WAS PERFORMED BASED ON THE X-RAY IMAGE RECEIVED. THE X-RAY IMAGE WAS REVIEWED, AND THE COMPLAINT CONDITION IS NOT CONFIRMED. THE IMPLANTED PLATE SHOWS NO SIGNS OF BREAKAGE OR DEFORMATION IN THE PROVIDED IMAGE. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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. NO LOT NUMBER WAS PROVIDED OR FOUND IN THE PHOTOS, THEREFORE NO DHR COULD BE PERFORMED. IF A VALID LOT NUMBER IS PROVIDED OR THE PHYSICAL DEVICE RETURNED, THE DHR WILL BE REVISITED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGE) THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT : NO LOT NUMBER WAS PROVIDED OR FOUND IN THE PHOTOS, THEREFORE NO DHR COULD BE PERFORMED. IF A VALID LOT NUMBER IS PROVIDED OR THE PHYSICAL DEVICE RETURNED, THE DHR WILL BE REVISITED. 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.

Additional Manufacturer Narrative

ADDITIONAL PRODUCT CODE: HRS, HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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. 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, A SYNTHES VA(VARIABLE ANGLE) DISTAL FEMUR PLATE AND SCREWS WILL BE REMOVED. THE FRACTURE RE-REDUCED AND REVISED ON (B)(6) 2021. THE REASON IS A FAILED PERI PROSTHETIC FRACTURE AND THE HARDWARE WAS REMOVED COMPLETELY. THIS REPORT IS FOR (1) 4.5 VA-LCP CURVED COND PL/8 HOLE/195/RT. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).