BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAUCH KNEE SNS

    MDR report key: 6034335 · Received October 17, 2016

    Report

    Report Number
    1836248-2016-00004
    Event Type
    Injury
    Date Received
    October 17, 2016
    Date of Event
    August 28, 2016
    Report Date
    December 8, 2016
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PENDING FULL EVALUATION. FINAL REPORT WILL BE SUBMITTED WITH EVALUATION CONCLUSION.

    Description of Event or Problem · 1

    ABOVE KNEE AMPUTEE PATIENT WAS WALKING ON THE SIDEWALK WHILE WEARING A MAUCH KNEE PROSTHETIC WHEN HE CLAIMS THE UNIT 'GAVE OUT' ON HIM CAUSING HIM TO FALL RESULTING IN A TROCHANTERIC FRACTURE. PATIENT WAS USING THE PRODUCT FOR THREE MONTHS PRIOR TO INCIDENT. PATIENT HAS MADE A FULL RECOVERY.

    Description of Event or Problem · 1

    ABOVE KNEE AMPUTEE PATIENT WAS WALKING ON THE SIDEWALK WHILE WEARING A MAUCH KNEE PROSTHETIC WHEN HE CLAIMS THE UNIT 'GAVE OUT' ON HIM CAUSING HIM TO FALL RESULTING IN A TROCHANTRERIC FRACTURE. PATIENT WAS USING THE PRODUCT FOR THREE MONTHS PRIOR TO INCIDENT. PATIENT HAS MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685902 MAUCH KNEE SNS PROSTHETIC MECHANICAL KNEE ISY OSSUR AMERICAS, INC. MKN71360

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention