BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 3915822 · Received July 7, 2014

    Report

    Report Number
    1644408-2014-00428
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K123982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS A DISLOCATION AND FRACTURING AFTER 1.7 YEARS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A 12 MINUTE 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 2 NON-CONFORMING MATERIAL REPORTS (NCMRS) ASSOCIATED WITH THIS PRODUCT. (B)(4). A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FOR THIS PART NUMBER FROM THIS LOT. THE ROOT CAUSE FOR THE PATIEN'S SHOULDER DISLOCATION AND FRACTURING WAS REPORTED AS A FALL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT FALLING AND DISLOCATING HER SHOULDER WITH SOME FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393560 TURON SHOULDER TURON ALL-POLY KEELED GLENOID 42MM KWS ENCORE MEDICAL, L.P. 191G1016

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 520-46-124,LOT 54003847| 520-00-000,LOT 878C1161