BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 26X58MM

    MDR report key: 1695752 · Received May 18, 2010

    Report

    Report Number
    2249697-2010-00546
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 26, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE X-RAYS AND MEDICAL RECORDS WERE REQUESTED, BUT NOT PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ABOVE LISTED IMPLANTS WERE IMPLANTED BY ANOTHER SURGEON AT ANOTHER HOSPITAL IN A HEMIARTHROPLASTY PROCEDURE FOR A VASCULAR NECROSIS. THE UH1-58-26 AND THE 6260-9-126 ABOVE WERE EXPLANTED AND THE HIP WAS CONVERTED TO A TOTAL HIP DUE TO GROIN PAIN. THE FOLLOWING WERE IMPLANTED: 1235-2-601 ((B) (4)) ADM CUP 60MM RIGHT, 1236-2-860 ((B) (4)) ADM X3 INSERT 28/60, 17-0000F (MJE3PW) V40 TO CTAPER ADAPTER SLEEVE AND 18-2805 ((B) (4)) BIOLOX DELTA CTAPER HEAD 28MM +5."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UHR BIPOLAR 26X58MM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA 98077201

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R