BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 28F

    MDR report key: 1903511 · Received November 16, 2010

    Report

    Report Number
    2249697-2010-01543
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ABOVE LISTED CONSTRAINED INSERT WAS FOUND TO BE DISASSOCIATED FROM THE TRITANIUM ACETABULAR SHELL (B)(4) (LOT L2MMKE). THE CONSTRAINED LINER WAS NOT FOUND TO BE BROKEN. THE LINER WAS REPLACED WITH A NEW (B)(4) (LOT E3JMHE)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG CONSTRAINED INSERT 28F IMPLANT KWZ STRYKER ORTHOPAEDICS MAHWAH NA MHATWE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R