BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 2864314 · Received December 5, 2012

    Report

    Report Number
    1644408-2012-00641
    Event Type
    Other
    Date Received
    December 5, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K950651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 4.1 YEARS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT. THE TAPER WAS OUT OF SPECIFICATION AND WAS DISPOSITIONED RETURN TO VENDOR AND NOT USED IN THE LOT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE FIRST COMPLAINT FOR THIS PART NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO THE ACCIDENT. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT GOT IN AN ACCIDENT AND DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER OFFSET HUMERAL HEAD HSD ENCORE MEDICAL, L.P. 53800943

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention (B)(4), LOT 53830141| (B)(4), UNK