BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURON SHOULDER

    MDR report key: 3932729 · Received July 14, 2014

    Report

    Report Number
    1644408-2014-00448
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K123982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE PATIENT'S PEGGED GLENOID DISLODGED. ONE OF THE PARTS EXPLANTED WAS A STEM THAT WAS IMPLANTED AT THE PRIMARY SURGERY FOR WHICH THE SURGERY DATE IS UNKNOWN. ALL OTHER COMPONENTS EXPLANTED AT THIS REVISION WERE IMPLANTED ON (B)(6) 2014 AT THE FIRST REVISION. 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. HOSPITALIZATION - INITIAL OR PROLONGED WAS REQUIRED. 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 SECOND REVISION TO THIS PATIENT CAUSED BY A DISLODGING OF THE SHOULDER GLENOID (REFER TO (B)(4)). THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 192G1076, THE FORTH TRAUMA COMPLAINT AGAINST THE PART NUMBER. THERE HAVE BEEN A TOTAL OF (B)(4) COMPLAINTS FOR THIS PART NUMBER. THE ROOT CAUSE FOR THE PATIENT'S PEGGED GLENOID DISLODGING WAS TRAUMA TO THE SHOULDER RESULTING FROM A PATIENT FALL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - DUE TO THE PATIENT DISLODGING HIS SHOULDER; HE HAD SLIPPED AND FALLEN WHILE DOING YARD WORK. THE FALL CAUSED THE PEGGED GLENOID TO DISLODGE FOR THE SECOND TIME. AFTER THE PREVIOUS REVISION ON (B)(6), THE SURGEON WARNED THE PATIENT THAT A REVERSE WAS HIS LAST OPTION AND ADVISED THE PATIENT NOT TO RESUME FULL DUTY UNTIL ADVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409825 TURON SHOULDER TURON ALL-POLY KEELED GLENOID 46MM KWS ENCORE MEDICAL, L.P. 192G1076

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R 520-01-010| 520-46-020, LOT 919C1026| 520-00-000, LOT 878C1335