BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED ACETABULAR INSERTS

    MDR report key: 1022752 · Received March 31, 2008

    Report

    Report Number
    2249697-2008-00078
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWB
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO, HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTRAINED ACETABULAR INSERTS IMPLANT KWB STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention