BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIT'CANC' SCREW 6.5 DIA X 30MMTRIATHLON TOTAL KNEE SYSTEM

    MDR report key: 2960981 · Received February 14, 2013

    Report

    Report Number
    0002249697-2013-00672
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K072575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING USING AN EXPIRED PRODUCT INVOLVING A KNEE SCREW WAS REPORTED. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT AN EXPIRED DEVICE WAS USED. HOWEVER, THERE IS NO EVIDENCE THAT IT IS MANUFACTURING RELATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4): DEVICE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED ON PATIENT DURING A LEFT PRIMARY KNEE REPLACEMENT. THIS WAS NOTICED AFTER THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED ON PATIENT DURING A LEFT PRIMARY KNEE REPLACEMENT. THIS WAS NOTICED AFTER THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64363 VIT'CANC' SCREW 6.5 DIA X 30MMTRIATHLON TOTAL KNEE SYSTEM IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH 25203302

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other