BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC CVD 8MM SZ4

    MDR report key: 2211715 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14141
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K830927
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED TIBIAL INSERT CONFIRMED ANTICIPATED WEAR FOR A POLYETHYLENE KNEE DEVICE IMPLANTED FOR APPROXIMATELY 18-1/2 YEARS. THE INVESTIGATION DID FIND EVIDENCE OF ENTRAPPED THIRD BODY DEBRIS WHICH COULD LEAD TO ACCELERATED WEAR. NO EVIDENCE WAS FOUND OF PRODUCT FAILURE AND THE NEED FOR CORRECTIVE IS NOT INDICATED. IN ADDITION, THE PRODUCT CODE IS AN OBSOLETE ITEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF A LOOSE TIBIAL TRAY AT THE BONE/CEMENT INTERFACE WITH COMPETITOR CEMENT. POLY WEAR OF THE INSERT AND OSTEOLYSIS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC CVD 8MM SZ4 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention