BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 3122610 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00279
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMEDY A FAILED ROTATOR CUFF AFTER 10.4 MONTHS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS KEPT 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 25TH COMPLAINT FOR THIS PART NUMBER: THREE REVISION SURGERIES, FIVE DUE TO TRAUMA, ONE FOR DEVICE LOOSENING, TEN FOR STABILITY/POOR JOINT ISSUES, TWO DUE TO DISLOCATION, ONE FOR WEAR/EXCESSIVE WEAR, AND THREE DUE TO PAIN. THIS IS THE FIRST 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

    SECOND REVISION SURGERY - CONVERTED TO REVERSE BECAUSE OF PATIENT'S FAILED ROTATOR CUFF. REFERENCE 1ST REVISION - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214546 FOUNDATION KNEE PRIMARY HUMERAL STEM, MALE TAPER KWS ENCORE MEDICAL, L.P. 269142

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention (B)(4), LOT 257422| (B)(4), LOT 53973233