BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOIMPLANT TECHNOLOGIES INC., ALPHA HIP SYSEM

    MDR report key: 1543977 · Received October 2, 2009

    Report

    Report Number
    MW5013623
    Event Type
    Injury
    Date Received
    October 2, 2009
    Date of Event
    September 21, 2009
    Report Date
    October 2, 2009
    Manufacturer
    PINNACLE HOLDING INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - UNK PT SYMPTOMS. REC'D CALL FROM ANOTHER REP THAT SURGEON REVISING HIP 8, NEEDED TRIALS 8 IMPLANTS. SURGEON STATED THAT THERE WAS LOOSENING OF CUP DOCUMENTED BY BONE SCAN. FACILITY 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 ACQUISITION OF THE OTI PRODUCT LINES, OTI -NOW KNOWN AS PINNACLE HOLDING INC.-AGREED TO ASSUME ALL REGULATORY RESPONSIBILITIES FOR PRODUCT IMPLANTED PRIOR TO FACILITY'S ACQUISITION OF THEIR PRODUCT LINES IN 2005. THE INFO IN THIS REPORT AND ANY ASSOCIATED PARTS WILL BE FORWARDED TO PINNACLE HOLDING, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOIMPLANT TECHNOLOGIES INC., ALPHA HIP SYSEM ALFA CLUSTER HOLE METAL SHELL KWB PINNACLE HOLDING INC. S94008
    2 OSTEOIMPLANT TECHNOLOGIES INC., ALPHA HIP SYSTEM ALFA CLUSTER HOLE METAL SHELL KWB PINNACLE HOLDING INC.
    3 OSTEOIMPLANT TECHNOLOGIES INC., ALPHA HIP SYSTEM ALFA CLUSTER HOLE METAL SHELL KWB PINNACLE HOLDING INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability