BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UHR BIPOLAR 28X42MM

    MDR report key: 2090559 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00525
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2011-00524.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "LOCKING RING WAS FOUND TO BE UNATTACHED AND IN PLASTIC INSERT INSIDE OF IMPLANT PACKAGING PRIOR TO SURGERY. SURGERY TEAM REATTACHED THE LOCKING RING AND WAS ABLE TO SEAT THE IMPLANT. PUT HEAD INTO LINER. IMPLANT/LOCKING RING FAILED DURING RANGE OF MOTION TEST." DATE: (B)(6) 2011, ADDITIONAL INFO RECEIVED. AFTER THE IMPLANT WAS INSERTED IN TO THE SECURFIT CUP AND LOCKED INTO PLACE THE HEAD WAS INSERTED INTO THE CONSTRAINED BIPOLAR PART OF THE IMPLANT. AFTER RANGE OF MOTION, THE BIPOLAR PART OF THE IMPLANT CAME OUT OF THE OUTSIDE LINER SO THE BIPOLAR IMPLANT WAS ATTACHED TO THE HEAD ON THE STEM AND THE OUTSIDE PART OF THE CONSTRAINED LINER WAS STILL ATTACHED TO THE SECURFIT SHELL. IT WAS TWO DIFFERENT PROBLEMS WITH THE IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UHR BIPOLAR 28X42MM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA MJK7JM

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention