BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT PSL HA ACET SHELL

    MDR report key: 1526036 · Received November 9, 2009

    Report

    Report Number
    2249697-2009-00776
    Event Type
    Injury
    Date Received
    November 9, 2009
    Date of Event
    October 9, 2009
    Report Date
    October 9, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWB
    PMA / PMN Number
    K911728
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RELEASED BY THE HOSPITAL; THEREFORE, NOT RETURNED TO THE MANUFACTURER. THE LOT CODE FOR THE REPORTED DEVICE WAS NOT PROVIDED EITHER. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REVISED DUE TO CUP LOOSENING. REMOVED CUP, INSERT AND HEAD. REPLACED WITH ZIMMER CUP AND POLY WITH 06-3600 STRYKER HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT PSL HA ACET SHELL IMPLANT KWB STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention