BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 3180043 · Received June 13, 2013

    Report

    Report Number
    1644408-2013-00323
    Event Type
    Other
    Date Received
    June 13, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    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 TO REMEDY A PATIENT'S FAILED ROTATOR CUFF AFTER 3.75 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 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 12TH COMPLAINT FOR THIS PART NUMBER: SIX FOR STABILITY/POOR JOINT, TWO DUE TO INFECTION, ONE FOR SURGICAL TECHNIQUE, ONE DUE TO PAIN, ONE DUE TO TRAUMA, AND ONE FOR FIXATION. THIS IS THE SECOND COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE FAILED ROTATOR CUFF COULD NOT BE DETERMINED WITH CONFIDENCE. 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 WAS SUFFERING FROM A FAILED ROTATOR CUFF AND REQUIRED A REVISION FROM THE HEMIARTHROPLASTY TO A REVERSE SHOULDER PROSTHESIS. THE INITIAL IMPLANTS WERE REMOVED AND THE REVERSE SHOULDER PROSTHESIS WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269475 FOUNDATION SHOULDER PRIMARY HUMERAL STEM, MALE TAPER KWS ENCORE MEDICAL, L.P. 776C1001

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 503-50-022, LOT 53881482