BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG POSTLIP INSERT S2.5 8MM

    MDR report key: 2920039 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-11113
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEPUY MATERIAL SCIENCE EXAMINED THE SUBMITTED DEVICE AND CONFIRMED ANTICIPATED WEAR FOR A POLYETHYLENE KNEE DEVICE IN VIVO FOR APPROXIMATELY FIFTEEN YEARS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO MANUFACTURING DEVIATION, MATERIAL DEFECTS, OR ANOMALIES WERE FOUND. NO EVIDENCE WAS FOUND OF PRODUCT FAILURE AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN ATTRIBUTED TO AN UNRESURFACED PATELLA. MILD POLY WEAR AND OSTEOLYSIS WERE ALSO FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25557 PFCSIG POSTLIP INSERT S2.5 8MM TIBIAL KNEE INSERT JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 33233A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention