BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER SYSTEM

    MDR report key: 1993456 · Received February 11, 2011

    Report

    Report Number
    1644408-2010-00675
    Event Type
    Other
    Date Received
    February 11, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REVISION SURGERY WAS IDENTIFIED AS PAIN AND WEAR AFTER 2.7 YEARS OF USE. THE INITIAL COMPLAINT WAS NOT CLEAR ON THE REVISION BUT LATER WAS FOUND OUT TO BE DUE TO PAIN. THERE IS NO INFORMATION ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ONE NON-CONFORMING MATERIAL REPORT ASSOCIATED WITH THIS PRODUCT, DISPOSITIONED AS RETURN TO VENDOR AND NOT USED IN THE LOT. THIS IS THE 10TH COMPLAINT FOR THIS PART NUMBER, THE FIRST COMPLAINT FOR THIS LOT NUMBER. OTHER COMPLAINTS INCLUDED 3 FOR INFECTION, 2 COMPLAINTS FOR DISLOCATION, ONE COMPLAINT FOR PAIN, ONE COMPLAINT FOR LOOSE JOINT, ONE COMPLAINT FOR UNSTABLE JOINT, AND ONE COMPLAINT FOR TRAUMA. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THE ROOT CAUSE WAS NOT DETERMINED WITH CONFIDENCE.

    Description of Event or Problem · 1

    REVISION SURGERY - DETAILS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER SYSTEM HUMERAL SOCKET KWS 53885906

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (B)(4), LOT 53830179| (B)(4), LOT 53908041