BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT M/S PSL SHELL 50MM

    MDR report key: 2901581 · Received January 3, 2013

    Report

    Report Number
    2249697-2012-02826
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K903636
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REMOVED OMNIFIT LINER AND 3 SCREWS. SURGEON SAID CUP WAS LOOSE. IMPLANTED ZIMMER CUP, SCREWS, AND 40MM LINER. A 40MM-5 C-TAPER HEAD WAS TRIALED ON THE REMAINING SECUR FIT STEM. A RANGE OF MOTION WAS PERFORMED AND THEN THE ACTUAL C-TAPER HEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200 OMNIFIT M/S PSL SHELL 50MM IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R