BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3902460 · Received June 30, 2014

    Report

    Report Number
    1644408-2014-00402
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K100741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REPLACE THE PATIENTS LOOSE STEM AFTER 4.5 MONTHS OF PATIENT USE. THE HEALTHCARE PROFESSIONAL INDICATED 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 FROM THIS LOT. THE ROOT CAUSE FOR THE DEVICE LOOSENING WAS REPORTED AS AN ISSUE WITH THE PATIENT'S ANATOMY. 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 STEM IN THE HUMERUS BEING LOOSE/TOGGLING. THE DISTAL PORTION OF THE STEM WAS MOVING ANTERIOR TO POSTERIOR. THIS WAS DUE TO THE PATIENTS ANATOMY AND NOT THE IMPLANT FAILING THAT CAUSED THE ISSUE. THE SURGEON REPLACED THE IMPLANT TO AVOID A POSSIBLE INFECTION IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380249 RSP SHOULDER RSP MONOBLOCK PRIMARY HUMERAL STEM 8 X 101MM KWS ENCORE MEDICAL, L.P. 979F1057

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 508-00-032, LOT 855C1256