BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CAPTURE - DISTAL RESECTION

    MDR report key: 5808131 · Received July 20, 2016

    Report

    Report Number
    0002249697-2016-02384
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 16, 2016
    Report Date
    June 23, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING SEATING/LOCKING ISSUE INVOLVING A MODULAR CAPTURE ¿ DISTAL RESECTION WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: DURING THE FUNCTION INSPECTION THE DISTAL RESECTION GUIDE WAS ABLE TO SNAP IN WITH THE MODULAR CAPTURE. THE DISTAL RESECTION GUIDE HELD SECURELY ONTO THE MODULAR CAPTURE AS INTENDED WITH NO SEPARATION TRYING TO PULL APART. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES 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 EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE DURING THE FUNCTIONAL INSPECTION THE DISTAL RESECTION GUIDE WAS ABLE TO SNAP IN WITH THE MODULAR CAPTURE. THE DISTAL RESECTION GUIDE HELD SECURELY ONTO THE MODULAR CAPTURE AS INTENDED WITH NO SEPARATION TRYING TO PULL APART. THE EVENT COULD NOT BE REPLICATED SINCE THE DISTAL RESECTION GUIDE SNAPPED INTO THE MODULAR CAPTURE AS INTENDED.

    Description of Event or Problem · 1

    THE CAPTURE WOULD NOT LOCK INTO THE CUTTING BLOCK. USED WITHOUT CAPTURE.

    Description of Event or Problem · 1

    THE CAPTURE WOULD NOT LOCK INTO THE CUTTING BLOCK. USED WITHOUT CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462604 MODULAR CAPTURE - DISTAL RESECTION PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 15ER9TF1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other