BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPOCA

    MDR report key: 6077705 · Received November 3, 2016

    Report

    Report Number
    2520274-2016-15182
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: KWT. THIS REPORT IS FOR UNKNOWN EPOCA/UNKNOWN LOT NUMBER. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA ORIGINAL IMPLANT DATE SOMETIME BETWEEN 5-7 YEARS AGO. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4): IT WAS REPORTED THAT THIS PATIENT UNDERWENT A REVISION SURGERY DUE TO POLYMETRIC WEAR AND POST-OP DEGENERATIVE CUFF FAILURE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON USED THE EPOCA SHOULDER SYSTEM PREDOMINANTLY IN OSTEOARTHRITIC PATIENTS FOR WHICH HE PERFORMED A TOTAL PROSTHETIC REPLACEMENT USING THE METAL BACKED GLENOID. THE SURGEON HAS HAD TO PERFORM REVISIONS DUE TO POLYMETRIC WEAR. THEY PRESENT TO CLINIC WITH DETERIORATING FUNCTION AND PAIN FOLLOWING GOOD INITIAL POST-OP IMPROVEMENTS. HE REPORTS THE REVISIONS ARE BEING PERFORMED BETWEEN 5-7 YEARS POST-OPERATIVELY. THIS COMPLAINT INVOLVES 1 PART. COMMENT - THE AFFILIATE HAD TO CREATE FOUR COMPLAINTS: (B)(4): REVISION DUE TO POLYMETRIC WEAR - GLENOID POSITION; (B)(4): REVISION DUE TO POLYMETRIC WEAR - FUNCTIONAL WEAR; (B)(4): REVISION DUE TO POLYMETRIC WEAR - POST-OP DEGENERATIVE CUFF FAILURE; (B)(4): REVISION PLANNED, UNKNOWN WHEN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726465 EPOCA PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention