BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 2861413 · Received November 29, 2012

    Report

    Report Number
    1644408-2012-00634
    Event Type
    Other
    Date Received
    November 29, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    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 CONVERT FROM A FOUNDATION SYSTEM TO A REVERSE SHOULDER PROSTHESIS SYSTEM AFTER 5.3 YEARS 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. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWS THIS IS THE 28TH COMPLAINT FOR THIS PART NUMBER: EIGHT DUE TO STABILITY/POOR JOINT, SEVEN DUE TO INFECTION, SIX TRAUMAS, THREE DISLOCATIONS, ONE PACKAGING ISSUE, ONE CONVERSION, AND ONE DUE TO PAIN. THIS IS THE FIRST COMPLAINT FOR THIS LOT NUMBER. THE ROOT CAUSE FOR THE CONVERSION WAS DUE TO A TORN ROTATOR CUFF. 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 WAS SUFFERING FROM A MASSIVE CUFF TEAR SEVERAL YEARS AFTER A TOTAL SHOULDER ARTHROPLASTY. THE PREVIOUS IMPLANTS WERE REMOVED AND THE PT WAS REVISED TO A REVERSE SHOULDER PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER PRIMARY HUMERAL STEM, MALE TAPER KWS ENCORE MEDICAL, L.P. 53862065

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention (B)(4), LOT 53834734| (B)(4), LOT 53851934