BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #2 - 9MM

    MDR report key: 4243301 · Received November 11, 2014

    Report

    Report Number
    0002249697-2014-04226
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE DAMAGED DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED IN THE PROCEDURE. PROBABLY, THE INSERT WAS BROKEN DURING REMOVING AFTER TRIAL.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED IN THE PROCEDURE. PROBABLY, THE INSERT WAS BROKEN DURING REMOVING AFTER TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725986 MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #2 - 9MM INSTRUMENT MBH STRYKER ORTHOPAEDICS-MAHWAH PPM5F06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other