BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2272460 · Received September 28, 2011

    Report

    Report Number
    1644408-2011-00524
    Event Type
    Other
    Date Received
    September 28, 2011
    Date of Event
    September 15, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, AN AGENT INFORMED DJO SURGICAL THAT A HIP REVISION SURGERY HAD OCCURRED. THE AGENT REPORTED THE FOLLOWING: PT IS DISLOCATED (28 MM FEMORAL HEAD OTI). ORIGINAL SURGERY DATE (B)(6) 1992. DJO SURGICAL RECEIVED A 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 (DJO SURGICAL) 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) 2006. THIS INFO HAS BEEN FORWARDED TO (B)(6).

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN KWY ENCORE MEDICAL, L.P. 8957D280

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention