4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. PART # 02.124.413. LOT NUMBER: 85P1799. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 19 JAN 2021. SUPPLIER: WRIGHTS LANE SYNTHES USA PRODUCTS LLC. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. 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 (B)(6) 2022 THERE WAS A REMOVAL OF THE VARIABLE ANGLE (VA) CONDYLE PLATE AND CORRESPONDING SCREWS DUE TO NONUNION/MALUNION. THE SURGEON REMOVED THE PLATE AND SCREWS, REALIGNED THE FEMUR, INSERTED IM NAIL, AND INSERTED BONE GRAFT OBTAINED VIA RADIOIMMUNOASSAY (RIA) PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR (1) 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT. THIS IS REPORT 1 OF 12 FOR COMPLAINT (B)(4).