BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2861428 · Received November 29, 2012

    Report

    Report Number
    1644408-2012-00636
    Event Type
    Other
    Date Received
    November 29, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER INVESTIGATION AND MULTIPLE SEARCHES OF THE DATABASE, NO SURGERIES WERE PERFORMED ON THIS PATIENT. IT WAS DETERMINED THAT THE PRIMARY SURGERY WAS PERFORMED BEFORE ENCORE/DJO SURGICAL WAS OPEN AND CONDUCTING BUSINESS. DJO SURGICAL IS NOT THE MANUFACTURER OF RECORD OF THIS DEVICE; THE MANUFACTURER IS UNKNOWN.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PRIMARY SURGERY WAS PERFORMED IN 1988 OR 1989. THE PT'S HEAD OR POLYETHYLENE WAS WORN DOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention