BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAUCH GAITMASTER LP PACKAGE

    MDR report key: 1414841 · Received July 2, 2009

    Report

    Report Number
    1836248-2009-00001
    Event Type
    Other
    Date Received
    July 2, 2009
    Date of Event
    May 15, 2009
    Report Date
    June 2, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    HTG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROSTHETIC KNEE JOINT INVOLVED IS A LOANER UNIT. WHEN A PATIENT SENDS THEIR KNEE IN TO BE SERVICED, OSSUR SUPPLIES A REPLACEMENT UNIT. THE REPLACEMENT UNIT IS RETURNED TO OSSUR WHEN THE PATIENT RECEIVES THEIR SERVICED KNEE. EVALUATION SUMMARY: AS RECEIVED, THE DEVICE WAS FUNCTIONALLY TESTED. THE UNIT PERFORMED WITHIN THE SPECIFIED LIMITS OF ALL CHARACTERISTICS. THE DEVICE WAS THEN FITTED TO AN OSSUR EMPLOYEE AND WORN FOR 24 HOURS. NO MALFUNCTIONS WERE DETECTED. THE KNEE JOINT PERFORMED WITHOUT ISSUE.

    Description of Event or Problem · 1

    "PATIENT (B)(6) WAS USING LOANER (B)(4) FELL AND CUT LEG OPEN. KNEE WENT FREE AND CAME FROM UNDERNEATH PATIENT. PATIENT WAS WALKING ON FLAT SURFACE." "FROM DEAD STOP WENT TO TAKE A STEP FROM A FLAT SURFACE AND KNEE BUCKLED FROM UNDERNEATH PATIENT." PATIENT'S LOWER SOUND LEG REQUIRED STITCHES TO CLOSE LACERATION. TYPICAL FUNCTION OF INVOLVED EXTERNAL PROSTHETIC KNEE - WHEN WEIGHT IS LOADED ON HEAL, JOINT LOCKS IN EXTENSION. WHEN WEIGHT IS APPLIED TO TOE, LOCK RELEASES ALLOWING KNEE TO TRANSFER TO FLEXION. THE PATIENT FEELS THAT THE KNEE JOINT RELEASED PREMATURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAUCH GAITMASTER LP PACKAGE HTG OSSUR AMERICAS FRM01803U NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention