BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 22X42MM

    MDR report key: 3103204 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01597
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 01-2200, LOT # 11868405/197374B, DESCRIPTION: LFIT MORSE TAPER HEAD. CAT # 1035-0730, LOT # 12327702/210812R, DESCRIPTION: OMNIFIT - AD HIP STEM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR AND A PSEUDOTUMOR INVOLVING A UHR BIPOLAR 22X42MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS THE REPORTED DEVICE, DATED X-RAYS, AND PATIENT MEDICAL RECORDS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A PATIENT HAD A BHA IN 1987. RECENTLY, SHE COMPLAINED A HIP PAIN AND A SURGEON NOTICED A PSEUDOTUMOR INTO HER HIP ON A CLINICAL IMAGING. THEREFORE, THE SURGEON PERFORMED TO ENUCLEATE THE PSEUDOTUMOR. THE SURGEON FOUND PE INTO THE PSEUDOTUMOR THROUGH A PATHOLOGICAL EXAMINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A PATIENT HAD A BHA IN 1987. RECENTLY, SHE COMPLAINED A HIP PAIN AND A SURGEON NOTICED A PSEUDOTUMOR INTO HER HIP ON A CLINICAL IMAGING. THEREFORE, THE SURGEON PERFORMED TO ENUCLEATE THE PSEUDOTUMOR. THE SURGEON FOUND PE INTO THE PSEUDOTUMOR THROUGH A PATHOLOGICAL EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204289 UHR BIPOLAR 22X42MM IMPLANT KWL STRYKER ORTHOPAEDICS-MAHWAH 93T129/195662E

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention