BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2823650 · Received October 25, 2012

    Report

    Report Number
    1644408-2012-00571
    Event Type
    Other
    Date Received
    October 25, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    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 IDENTIFIED AS DISLOCATION AFTER 1.1 MONTHS OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. 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. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. (B)(4). THE ROOT CAUSE FOR THE DISLOCATION WAS MOST LIKELY DUE TO PATIENT ACTIVITY, AS THE PATIENT WAS NON-COMPLIANT AND BEGAN WORKING OUT TWO WEEKS POST-OP, RESULTING IN DISLOCATION. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. 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 HAD A REVERSE SHOULDER PROSTHESIS DONE FIVE WEEKS AGO, AND BEGAN WORKING OUT TWO WEEKS POST-OPERATION. AS A RESULT, HE RECENTLY DISLOCATED. THE SURGEON REMOVED THE SHELL AND INSERT AND TRAILED A +8 SEMI CONSTRAINED MODULAR CONSTRUCT AND FOUND THAT TO BE STABLE. THE SURGEON THEN REVISED THE PT USING THAT COMBINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL, NEUTRAL KWS ENCORE MEDICAL, L.P. 848C1225

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (B)(4), LOT 855C1143