BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB GVF INS 2.5 12.5MM

    MDR report key: 1760476 · Received July 15, 2010

    Report

    Report Number
    1818910-2010-04584
    Event Type
    Injury
    Date Received
    July 15, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 18, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K033272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 OTHER 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 ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS LOOSE MEDIALLY, FOUND POLYETHYLENE WEAR OF INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA STAB GVF INS 2.5 12.5MM JWH DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS NA Y1BJ84

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention