BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT PSL HA ACET SHELL

    MDR report key: 2850959 · Received November 20, 2012

    Report

    Report Number
    2249697-2012-02426
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K911728
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE REPORTED DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED AT THE HOSPITAL AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) REVISED THE CUP WHICH WAS LOOSE IN THE ACETABULUM AND HELD IN BY THE SCREWS. THE SHELL LINER, SCREWS AND 28 MM PLUS 10 MM HEAD WERE REMOVED AND REPLACED WITH A TRITANIUM SHELL, A 36 LINER AND 4 SCREWS, AND A 36 PLUS 10 MM HEAD. THE STEM WAS WELL FIXED AND WAS NOT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT PSL HA ACET SHELL IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 7371602

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention