BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB XLK INS 3 10MM

    MDR report key: 2133398 · Received June 13, 2011

    Report

    Report Number
    1818910-2011-10371
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 14, 2011
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    K040166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADD'L REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR LOOSE TIBIA AND FEMORAL COMPONENTS AT CEMENT/IMPLANT MANTLE. UNK MFR OF CEMENT. POLYETHYLENE WEAR NOTED ON TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA STAB XLK INS 3 10MM 87 JWH JWH DEPUY (IRELAND) NA 2148206

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention