BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT, #5 ANATOMIC

    MDR report key: 1073793 · Received July 9, 2008

    Report

    Report Number
    MW5007597
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 9, 2008
    Manufacturer
    OSTEOIMPLANT TECHNOLOGIES, INC/PINNACLE HOLDING
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY-PT DEVELOPED A HEART INFECTION AND IT SPREAD TO HIS KNEE RESULTING IN A POLY EXCHANGE. POLY DID NOT FAIL, EXCHANGE WAS DUE TO INFECTION. THIS REPORT IS A CORRECTION TO THE REPORT PREVIOUSLY SUBMITTED.

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT DEVELOPED A HEART INFECTION AND IT SPREAD TO HIS KNEE RESULTING IN A POLY EXCHANGE. POLY DID NOT FAIL, EXCHANGE WAS DUE TO INFECTION. 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 ON 02/22/05. THIS INFO HAS BEEN FORWARDED TO PINNACLE HOLDING INC..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL INSERT, #5 ANATOMIC HSH OSTEOIMPLANT TECHNOLOGIES, INC/PINNACLE HOLDING UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability