BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC PLI 8MM SZ 2

    MDR report key: 1051129 · Received May 21, 2008

    Report

    Report Number
    1818910-2008-01700
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMS POLYETHYLENE WEAR. PROD INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. A CONCLUSIVE ROOT CAUSE COULD NOT BE IDENTIFIED, AS PREFERENTIAL LOADING OF THE FEMORAL COMPONENT ONTO THE TIBIAL INSERT, LENGTH OF TIME INSERTED (15 YRS), AND METHOD OF STERILIZATION ARE ALL POSSIBLE CONTRIBUTING FACTORS. BASED ON THE INABILITY TO IDENTIFY THE PRIMARY ROOT CAUSE OF THE POLYETHYLENE WEAR, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN ADDITION, THE PROD CODE IS A DISCONTINUED ITEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF OSTEOLYSIS AND WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC PLI 8MM SZ 2 87JWH JWH DEPUY - RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention