BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3971314 · Received July 31, 2014

    Report

    Report Number
    1644408-2014-00498
    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
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE LOSS OF MOTION IN THE PATIENT'S SHOULDER AFTER 6.7 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 AGAINST LOT NUMBER 856C1077. (B)(4). THIS EVENT IS DEEMED TO BE NON-PRODUCT RELATED AND THE ROOT CUASE FOR THE LOSS OF MOTION IS A PATIENT FALL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - AFTER A FALL THE PATIENT COMPLAINED OF LOSS OF RANGE OF MOTION. THE SURGEON DECIDED TO DOWNSIZE THE GLENOSPHERE AND THE HUMERAL POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446369 RSP SHOULDER RSP STANDARD HUMERAL SOCKET INSERT 36MM KWS ENCORE MEDICAL, L.P. 856C1077

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 508-36-101, LOT 869C1163