BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 3180067 · Received June 13, 2013

    Report

    Report Number
    1644408-2013-00320
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS DISLOCATION AFTER 17 DAYS OF PATIENT USE. 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 BY THE HOSPITAL AND NOT RETURNED 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 SHOWS THIS IS THE 32ND COMPLAINT FOR THIS PRODUCT: ONE FIT ISSUE, 13 DUE TO DISLOCATION, ONE DUE TO TRAUMA, TWO REVISION SURGERIES, FIVE DUE TO INFECTION, TWO FOR DEVICE LOOSENING, ONE SURGICAL TECHNIQUE, THREE FOR STABILITY/POOR JOINT ISSUES, AND FOUR INDETERMINATE. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE DISLOCATION WAS DUE TO TRAUMA WHICH OCCURRED AS A RESULT FROM THE PATIENT'S DAUGHTER PULLING HER ARM. THE INFORMATION REVIEWED SHOWED THE PRODUCT MET ALL DESIGN, MATERIAL, AND MANUFACTURING SPECIFICATIONS. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT'S SHOULDER WAS DISLOCATED DUE TO THE DAUGHTER PULLING HER MOTHER'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269509 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 856C1056

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention