4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT

Description of Event or Problem

DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT UNDERWENT THE REMOVAL OF ATTUNE TKR AND DISTAL PERIPROSTHETIC PLATES AND SCREWS LEFT FEMUR DUE TO INFECTION IN LEFT KNEE. THIS PROCEDURE WAS TO REMOVE ALL COMPONENTS INCLUDING THE DISTAL PLATES AND SCREWS AND DEBRIDE, WASHOUT AND INSERT SPACER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THIS COMPLAINT IS RELATED TO COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A J&J EMPLOYEE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 02.124.409, LOT: L199828, MANUFACTURING SITE: (B)(4), SUPPLIER: N/A, RELEASE TO WAREHOUSE DATE: 28 NOV 2016, EXPIRATION DATE: N/A. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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.