VA-LCP CONDYLAR PLATE 4.5/5.0 R 10HO L23

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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. E1 INITIAL REPORTER ADDRESS LINE 1: (B)(6). 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 THERE WAS BREAKAGE OF THE DEVICE ON FEMORAL DIAPHYSIS. DISEASE HISTORY - (B)(6) 2019: MECHANICAL FALL FROM ITS HEIGHT WITH RECEPTION ON THE RIGHT SIDE. CLINICAL EXAMINATION: PAINFUL AND TOTAL FUNCTIONAL IMPOTENCE OF THE LOWER LIMB STRAIGHT. VICIOUS ATTITUDE OF THE LOWER LIMB: SHORTENING AND EXTERNAL ROTATION. NO SENSORY-MOTOR DEFICIT. INITIAL CARE: CLOSED FOCUS REDUCTION AND STABILIZATION BY STATIC LOCKED INTRAMEDULLARY NAILING. (B)(6) 2024: EMERGENCY DEPARTMENT CONSULTATION FOR MECHANICAL FALL AT HOME FOR TRAUMA OF THE RIGHT LOWER LIMB, WITHOUT SKIN BREAK-IN. X-RAY REVEALS DIAPHYSEAL FRACTURE OF THE DISTAL TIER OF THE COMMINUTED RIGHT FEMUR, WHICH OCCURS UNDER THE PFNA NAIL IMPLANTED IN 2019. OPERATION PERFORMED ON (B)(6) 2024: OSTEOSYNTHESIS OF DIAPHYSIAL FRACTURE OF THE FEMUR BY SYNTHES VA LCP EXTERNAL PLATE OF DISTAL FEMUR TO THE RIGHT. (B)(6) 2024: PAINFUL PRODROMES THEN SPONTANEOUS FALL RESPONSIBLE FOR A PAINFUL AND TOTAL FUNCTIONAL IMPOTENCE OF THE RIGHT LOWER LIMB WITH VICIOUS ATTITUDE. X-RAYS REVEAL - RUPTURE OF OSTEOSYNTHESIS MATERIAL (SCREWED PLATE) IN FRONT OF AN UNCONSOLIDATED FRACTURE OF THE DIAPHYSIS OF THE FEMUR. PATIENT CARE - (B)(6) 2024: CLOSED-FOCUS REDUCTION AND STABILIZATION BY LONG PROXIMAL FEMORAL LOCKED CENTROMEDULLARY NAILING. ABLATION OF THE SHORT PROXIMAL FEMORAL NAIL. DISTAL FEMORAL PLATE ABLATION. OSTEOSYNTHESIS BY PROXIMAL FEMORAL CENTROMEDULLARY NAILING WITH BIPOLAR LOCKING.

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. H3, H6: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER X-RAY AND PHOTOS WERE PROVIDED FOR REVIEW. THE X-RAY AND PHOTO INVESTIGATION REVEALED THE PLATE WAS OBSERVED IMPLANTED AND BROKEN FROM THE MIDDLE DISTAL AREA IN TWO FRAGMENTS. PHOTO OF THE IMPLANT EXPLANTED WAS ALSO OBSERVED AND A CRACK OVER THE SURFACE IS NOTABLE. THE OBSERVED CONDITION OF THE DEVICE CAN BE CONSISTENT WITH A COMPONENT FAILURE THAT WAS CAUSED BY EXPOSURE TO UNINTENDED FORCES, HOWEVER, A COMPLETE POTENTIAL CAUSE CAUSE CAN NOT BE ESTABLISHED. THE MODE OF FAILURE OF THE DEVICE IS MULTI-FACTORIAL AND CONSIDERATION MUST BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS SURGICAL PROCESS, PATIENT VARIABLES (E.G. ACTIVITY LEVEL AND USE), ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. ANY CONCLUSIONS FROM THE INVESTIGATIONAL INPUT PROVIDED HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. 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. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VA-LCP CONDYLAR PLATE 4.5/5.0 R 10HO L23 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW : PART NUMBER: 02.124.410S, LOT NUMBER: 4860P17, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 11 APR 2023, EXPIRATION DATE: 01 MAR 2033. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE FINISHED LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

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 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

ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE PLATE WAS IMPLANTED ON (B)(6) 2024 ON A DIAPHYSEAL FRACTURE AT THE END OF THE PFNA NAIL OF THE RIGHT FEMUR. THE PLATE FRACTURE WAS DIAGNOSED ON (B)(6) 2024 SURGERY RESUMED ON (B)(6) 2024 WITH OSTEOSYNT. 10X360MM 130° RIGHT TFNA 04037056S + HELICOIDAL BLADE FOR TFNA NAIL L.95MM TAN 04038395S + SCREW STARDRIVE LOCK D.5MM L.38MM 04005528S + SCREW STARDRIVE LOCK D.5MM L.48MM 04005538S PATIENT'S CURRENT CONDITION: SURGERY REVISION -NEW REHABILITATION - LOSS OF INDEPENDENCE REMOVAL OF THE FRACTURED PLATE AND REVISE IT WITH OSTEOSYNTHESIS MATERIAL. MONITORING OF PATIENTS WITH THIS TYPE OF IMPLANTED PLATE.