BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT-10 DEG.

    MDR report key: 2020662 · Received March 7, 2011

    Report

    Report Number
    9616680-2011-00113
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 8, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWZ
    PMA / PMN Number
    K063552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 MFR. ADD'L INFO (INCLUDING X-RAYS AND MED RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 2249697-2011-00264.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE CUP CAME LOOSE AND POLY WEAR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT SER. II INSERT-10 DEG. IMPLANT KWZ STRYKER ORTHOPAEDICS CORK NA ATUZ

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R