BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 3971298 · Received July 31, 2014

    Report

    Report Number
    1644408-2014-00497
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K123982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION WAS A FAILED GLENOID IMPLANT DUE TO COMPLICATIONS RELATED TO MULTIPLE SCLEROSES AFTER 2.1 YEARS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 191G1025. (B)(4). THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED AND THE ROOT CAUSE FOR THE GLENOID FAILURE IS THE PATIENT HAVING COMPLICATIONS FROM MULTIPLE SCLEROSES. THERE IS NO REPORTED INFORMATION THAT INDICATES A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THIS PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO COMPLICATIONS RELATED TO MULTIPLE SCLEROSIS, THE PATIENT'S GLENOID IMPLANT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446669 TURON SHOULDER TURON ALL-POLY KEELED GLENOID 42MM KWS ENCORE MEDICAL, L.P. 191G1025

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R (B)(4), LOT 878C1082| (B)(4), LOT 925C1009