BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA CRVD GVF INS 3 10MM

    MDR report key: 1080151 · Received July 18, 2008

    Report

    Report Number
    1818910-2008-03008
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K0033272
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED PAIN. BASED ON THE INVESTIGATION FINDINGS. 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 REVISED TO ADDRESS PAIN. POLY WEAR AND OSTEOLYSIS DISCOVERED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA CRVD GVF INS 3 10MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention