BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #6 - 11MM

    MDR report key: 5271807 · Received December 7, 2015

    Report

    Report Number
    0002249697-2015-04163
    Event Type
    Malfunction
    Date Received
    December 7, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE INVOLVING A TRIATHLON MODIFIED INSERT TRIAL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT INFORMATION WAS PROVIDED. THERE IS NO INDICATION PATIENT FACTORS CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IF THE DEVICE AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING ROM TRIALING AND INSERT EXTRACTION A PIECE OF THE 6X11 PS INSERT TRIAL BROKE OFF OF THE POSTERIOR MEDIAL CORNER. DR (B)(6) HAD TO RETRIEVE THE BROKEN PORTION FROM THE KNEE. WE OPENED A NEW SET OF 3-6 PS TRIALS TO COMPLETE LTK.

    Description of Event or Problem · 1

    DURING ROM TRIALING AND INSERT EXTRACTION A PIECE OF THE 6X11 PS INSERT TRIAL BROKE OFF OF THE POSTERIOR MEDIAL CORNER. DR (B)(6) HAD TO RETRIEVE THE BROKEN PORTION FROM THE KNEE. WE OPENED A NEW SET OF 3-6 PS TRIALS TO COMPLETE LTK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802177 MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #6 - 11MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH PPM8L65

    Patients

    Seq Age Sex Outcome Treatment
    1 Other