4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H3, H6 INVESTIGATION SUMMARY: THE PRODUCT WAS NOT RETURNED TO J&J MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTOS AND X-RAYS INVESTIGATION REVEALED NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. AS STATED ON THE E-IFU TRAUMA, INSTRUCTIONS FOR USE - PLATE AND SCREW IMPLANTS: AS WITH ALL MAJOR SURGICAL PROCEDURES, RISKS, SIDE EFFECTS AND ADVERSE EVENTS CAN OCCUR. WHILE MANY POSSIBLE REACTIONS MAY OCCUR, SOME OF THE MOST COMMON INCLUDE: PROBLEMS RESULTING FROM ANESTHESIA AND PATIENT POSITIONING (E.G. NAUSEA, VOMITING, DENTAL INJURIES, NEUROLOGICAL IMPAIRMENTS, ETC.), THROMBOSIS, EMBOLISM, INFECTION, EXCESSIVE BLEEDING, IATROGENIC NEURAL AND VASCULAR INJURY, DAMAGE TO SOFT TISSUES INCL. SWELLING, ABNORMAL SCAR FORMATION, FUNCTIONAL IMPAIRMENT OF THE MUSCULOSKELETAL SYSTEM, SUDECK¿S DISEASE, ALLERGY/HYPERSENSITIVITY REACTIONS, AND SIDE EFFECTS ASSOCIATED WITH HARDWARE PROMINENCE, MALUNION, NON-UNION. 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 NOT CONFIRMED AS THE OBSERVED CONDITION OF THE 4.5 VA-LCP CURVED COND PL/12 HOLE/266/RT WOULD HAVE NOT CONTRIBUTED TO THE REPORTED ADVERSE EVENT. 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. THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR HARDWARE REMOVAL SURGERY. PATIENT HAD INFECTION AND WAS DIAGNOSED WITH NON UNION.