4.5MM TI VA-LCP CRVD CONDYLAR PLATE/10H/230MM/RIGHT

Additional Manufacturer Narrative

DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. ADDITIONAL PROCODE: HWC, HRS COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DATE OF CONCOMITANT THERAPY IS (B)(6) 2021. 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. THE PHOTO WAS RETURNED TO DEPUY SYNTHESE FOR EVALUATION. THE DEPUY SYNTHESE TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE FROM THE PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT4.5 TI VA-LCP CRVD COND PL/10H/230/RT WAS BROKEN IN TWO PIECES. A REVIEW OF THE X-RAYS SHOWED A CLEAR FRACTURE IN THE LOWER THIRD OF THE DISTAL FEMUR SHAFT. NO OTHER ISSUES WERE FOUND. 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 SYNTHESE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR 4.5 TI VA-LCP CRVD COND PL/10H/230/RT. 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 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 ON AN UNKNOWN DATE, A FEMALE PATIENT UNFORTUNATELY FELL INJURING HER RIGHT FEMUR. ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION, RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE AND IMPLANTABLE BONE STIMULATOR PLACEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION OPEN REDUCTION INTERNAL FIXATION RIGHT SUPRACONDYLAR PERIPROSTHETIC FEMUR FRACTURE, PLACEMENT OF IMPLANTABLE BONE STIMULATOR, PLACEMENT OF ALLOGRAFT BONE DUE TO REFRACTURE OF RIGHT FEMUR AND INTERNAL HARDWARE FRACTURE. SHE HAS A DELAYED UNION AND FELT SIGNIFICANT PAIN IN HER LEFT THIGH. THIS REPORT IS FOR A 4.5MM TI VA-LCP CRVD CONDYLAR PLATE/10H/230MM/RIGHT. THIS IS REPORT 1 OF 10 FOR (B)(4).