BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RSP SHOULDER

    MDR report key: 3843853 · Received June 2, 2014

    Report

    Report Number
    1644408-2014-00335
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K100741
    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 DUE TO A DISLOCATION AFTER 35 DAYS OF PATIENT USE. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR REVISION. 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 FIRST COMPLAINT FOR A PART FROM THIS LOT. THE ROOT CAUSE FOR THE PATIENTS DISLOCATION COULD NOT BE DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    SECOND REVISION SURGERY - DUE TO THE PATIENT DISLOCATING 3-4 TIMES, THE SURGEON DECIDED TO EXCHANGE THE LINER AND ADD A SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321676 RSP SHOULDER RSP MONOBLOCK STANDARD HUMERAL SOCKET INSERT, +4 MM 32MM KWS ENCORE MEDICAL, L.P. 918F1049

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R