BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN KNEE

    MDR report key: 2660762 · Received July 11, 2012

    Report

    Report Number
    1644408-2012-00350
    Event Type
    Other
    Date Received
    July 11, 2012
    Date of Event
    June 20, 2012
    Report Date
    June 20, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DJO SURGICAL RECEIVED THIS COMPLAINT OF A REPORTABLE EVENT AND HAS DETERMINED THAT THE EXPLANTED DEVICE WAS MANUFACTURED AND IMPLANTED PRIOR TO FEBRUARY 22, 2005 BY OSTEOIMPLANT TECHNOLOGIES, INC. (OTI). AS PART OF ENCORE MEDICAL'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 FEBRUARY 22, 2005. THIS INFORMATION WILL BE FORWARDED TO (B)(4) AT PINNACLE HOLDING, INC., (B)(4).

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON PERFORMED A POLY EXCHANGE; DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN KNEE UNKNOWN JWH ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention