UNK - PLATES: CONDYLAR

Description of Event or Problem

THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 64 PATIENTS THAT WERE IMPLANTED WITH ANGLED BLADE PLATES. IMPLANTATION WAS BETWEEN (B)(6) 2000 TO (B)(6) 2023 AT (B)(6). PATIENT NUMBER 55. PATIENT IS A 21 YEAR OLD FEMALE. REASON FOR IMPLANTATION WAS FRACTURE FIXATION. POST OP COMPLICATIONS INCLUDED NONUNION, AVN (AVASCULAR NECROSIS). TREATMENT/INTERVENTION INCLUDED FEMORAL NECK REVISION ORIF (OPEN REDUCTION INTERNAL FIXATION), TOTAL HIP ARTHROPLASTY (THA). IMPLANT(S) INVOLVED: 95 DEGREE CONDYLAR PLATE; CORTEX SCREWS X5; 3.5 RECONSTRUCTION PLATE.

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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.