BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED

    MDR report key: 6072270 · Received November 2, 2016

    Report

    Report Number
    2520274-2016-15160
    Event Type
    Injury
    Date Received
    November 2, 2016
    Report Date
    October 26, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN EPOCA IMPLANTS/UNKNOWN LOTS. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. ADDITIONAL PRODUCT CODES: MBF AND HSD. A REVISION PROCEDURE HAS BEEN PLANNED BUT IT IS UNKNOWN IF IT HAS OCCURRED YET. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON USED THE EPOCA SHOULDER SYSTEM PREDOMINANTLY IN OSTEOARTHRITIC PATIENT FOR WHICH HE PERFORMED A TOTAL PROSTHETIC REPLACEMENT USING THE METAL BACKED GLENOID. A REVISION SURGERY IS PLANNED DUE TO IMPLANT WEAR; IT IS UNKNOWN IF/WHEN THAT PROCEDURE OCCURRED. THIS REPORT IS FOR AN UNKNOWN EPOCA IMPLANTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724973 PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED KWT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention