BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL POLY CONSTRAINED INSERT 50MM

    MDR report key: 1941010 · Received December 7, 2010

    Report

    Report Number
    2249697-2010-01680
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. ADD'L INFO WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IMPLANT SURGEON REPORTED FOLLOWING TO REP. "THE PT GOT A TRIDENT CEMENTED CONSTRAINED LINER DURING THE (B)(6) 2010. THE PT IS USING A WHEELCHAIR AND WHEN HE IS BENDING FORWARD FOR EXAMPLE TO TIE HIS SHOES THE CONSTRAINED LINER IS DISLOCATING. THE BIPOLAR PART IS STILL STABLE AND IN PLACE, BUT THE HEAD IS DISLOCATING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL POLY CONSTRAINED INSERT 50MM IMPLANT KWZ STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R