BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG POSTLIP INS SZ5 12.5MM

    MDR report key: 1031811 · Received April 17, 2008

    Report

    Report Number
    1818910-2008-01361
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED POLYETHYLENE WEAR. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. NO CONCLUSIONS COULD BE DRAWN ABOUT THE ROOT CAUSE OF THE POLYETHYLENE WEAR; HOWEVER, EVIDENCE WAS FOUND SUGGESTING POOR DEVICE ALIGNMENT AND PT ATTEMPTS TO HYPEREXTEND WERE LIKELY CONTRIBUTING FACTORS. BASED ON THE PERFORMED INVESTIGATION, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFCSIG POSTLIP INS SZ5 12.5MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention