BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1073792 · Received July 9, 2008

    Report

    Report Number
    MW5007596
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    May 29, 2008
    Report Date
    July 9, 2008
    Manufacturer
    PINNACLE HOLDING INC
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - ENCORE WAS NOTIFIED OF A PATIENT WITH A FAILED ACETABULAR. LINER AND SHELL REMOVED. 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 * ACETABULAR SHELL AND LINER KWB PINNACLE HOLDING INC F286

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Disability 470-55| FHM-028PM/F534