BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF CENT HIP 48X28 BRN

    MDR report key: 1031820 · Received April 18, 2008

    Report

    Report Number
    1818910-2008-01176
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 29, 2008
    Report Date
    March 29, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K821672
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES, SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COLD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DISLOCATION (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELF CENT HIP 48X28 BRN 87KWY KWY DEPUY ORTHOPAEDICS, INC. NA B3ND81

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention