BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. PACK: NO-HOLE CUP + CERAMIC INSERT CUP O.D.5

    MDR report key: 1915773 · Received November 29, 2010

    Report

    Report Number
    9616680-2010-00781
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT COMPLAINED OF GRINDING NOISE IN HIP. NO FALL REPORTED BY PT. PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII. PACK: NO-HOLE CUP + CERAMIC INSERT CUP O.D.5 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA G18507063

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention