BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOIMPLANT TECHNOLOGIES INC., ALFA II HIP SYSTEM

    MDR report key: 2228421 · Received March 19, 2009

    Report

    Report Number
    MW5021903
    Event Type
    Injury
    Date Received
    March 19, 2009
    Date of Event
    February 27, 2009
    Report Date
    March 19, 2009
    Manufacturer
    OSTEOIMPLANT TECHNOLOGIES INC., PINNACLE HOLDING INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - LOSS OF LEG LENGTH, FEMORAL COMPONENT LOOSE. ENCORE REC'D A COMPLAINT ABOUT A REPORTABLE EVENT. IT WAS 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 ON (B)(6) 2005. THE INFO IN THIS REPORT WILL BE FORWARDED TO (B)(6) AT PINNACLE HOLDING INC., (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOIMPLANT TECHNOLOGIES INC., ALFA II HIP SYSTEM MODULAR STEM JDI OSTEOIMPLANT TECHNOLOGIES INC., PINNACLE HOLDING INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Disability 497-28-350| 410-32-108