BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2214054 · Received August 2, 2011

    Report

    Report Number
    1644408-2011-00443
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE REVISION SURGERY WAS DUE TO PATIENT HAVING SCLERODERMA. DUE TO THE PATIENT'S CONDITION, THE SURGEON FELT IT WAS NECESSARY TO REMOVE ALL IMPLANTS. THE SURGEON DID NOT HAVE AN ISSUE WITH THE IMPLANTS, REPORTED AS FUNCTIONING NORMALLY. THE IMPLANTS WERE NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORD FOR THE REPORTED COMPONENTS INVOLVED WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOW THAT THE DEVICES HAD ALL RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE AND WERE WITHIN THEIR EXPIRATION DATES AT THE TIME OF SURGERY. A REVIEW OF THE DEVICE HISTORY RECORD, PRODUCT COMPLAINT REPORT HISTORY, AND STERILIZATION RECORDS SHOW THE COMPONENTS USED IN THE SURGERY MET STERILIZATION, DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO FINDINGS DURING THIS INVESTIGATION THAT INDICATE THE REPORTED DEVICES WERE THE SOURCE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    REVISION SURGERY - THE DETAILS ARE UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET, INSERT HSD ENCORE MEDICAL, L.P. 53958251

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 508-00-004