BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT

    MDR report key: 2113002 · Received January 23, 2009

    Report

    Report Number
    MW5020790
    Event Type
    Injury
    Date Received
    January 23, 2009
    Date of Event
    October 25, 2008
    Report Date
    January 23, 2009
    Manufacturer
    OSTEOIMPLANT TECHNOLOGIES, INC., -OTI-/PINNACLE HOLDING
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ENCORE RECEIVED ADD'L INFO ON A LEFT KNEE POLY SWAP DUE TO INFECTION. ENCORE RECEIVED 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 HAS BEEN FORWARDED TO (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL INSERT INSERT, TIBIAL #5 ANATOMIC HSH OSTEOIMPLANT TECHNOLOGIES, INC., -OTI-/PINNACLE HOLDING L430

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability