BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK STD INS HYLAMER M SZ2 12MM

    MDR report key: 876444 · Received July 3, 2007

    Report

    Report Number
    1818910-2007-02270
    Event Type
    Injury
    Date Received
    July 3, 2007
    Date of Event
    June 26, 2007
    Report Date
    June 26, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K940743
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN ADDITION, THE PRODUCT CODE IS A DISCONTINUED ITEM.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMK STD INS HYLAMER M SZ2 12MM 87KWY KWY DEPUY ORTHOPAEDICS, INC. NA 886490024

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention