BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMRS EXTENSION PIECE 30MM

    MDR report key: 1881125 · Received October 20, 2010

    Report

    Report Number
    9610726-2010-00366
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K023087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "GMRS PROXIMAL FEMUR. SURGEON REVISED BECAUSE PT WAS EXPERIENCING PAIN AROUND GROIN AND SOCKET WAS LOOSE. PLAN WAS TO TRY TO SHORTEN THE STEM, AND CEMENT IN A LOCKING SOCKET. REVISED THE CUP AND IMPLANTED A REVISION CUP WITH A CONSTRAINED LINER. CHANGED OUT THE HEAD, WAS ABLE TO SHORTEN THE STEM BY REMOVING GMRS EXTENSION PIECE. THE SURGEON CHOSE TO, AND REUSED THE PROXIMAL FEMORAL COMPONENT. (B)(4). THE CUP WAS A DEPUY CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMRS EXTENSION PIECE 30MM IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA LAPZE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention