BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP STEM

    MDR report key: 1073794 · Received July 9, 2008

    Report

    Report Number
    MW5007598
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 9, 2008
    Manufacturer
    OTI/PINNACLE HOLDING, INC
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT REC'D IMPLANTS 6 YEARS AGO. BEGAN HAVING PAIN THIS PAST YEAR. THE STEM FRACTURED ABOUT 6CM FROM THE TIP. ACETABULAR LINER WAS REPLACED AS CUP WAS WELL FIXED. REMOVED FEMORAL IMPLANTS, STEM, NECK, HEAD, AND ACETABULAR LINER ARE BEING RETURNED. SURGEON BELIEVES DISTAL FIXATION WAS ATTAINED, BUT NOT PROXIMAL AND STEM FRACTURED UNDER FATIGUE. ENCORE MEDICAL REC'D THE ABOVE COMPLAINT ABOUT A REPORTABLE EVENT AND HAS DETERMINED THAT THE MFR OF THE DEVICE IN QUESTION WAS OSTEOIMPLANT TECHNOLOGIES, INC. -OTI-. AS PART OF ENCORE'S ACQUISITION OF THE OTI PRODUCT LINES, OTI -NOW KNOWN AS PINNACLE HOLDING INC. - AGREED TO ASSUME ALL REGULATORY RESPONSIBILITIES FOR PRODUCT IMPLANTED PRIOR TO ENCORE'S ACQUISITION OF THEIR PRODUCT LINES IN 2005. THIS INFO HAS BEEN FORWARDED TO REP AT PINNACLE HOLDING INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP STEM KWY OTI/PINNACLE HOLDING, INC P169

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability FHM-028PM/R566| 470-50| 612-35