BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAUCH KNEE

    MDR report key: 2016977 · Received March 9, 2011

    Report

    Report Number
    1836248-2011-00001
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 7, 2011
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ISY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OSSUR IS CURRENTLY REVIEWING THE RESULTS OF THE EVALUATION CONDUCTED ON THIS DEVICE. WHEN OSSUR'S CONCLUSIONS ARE FINALIZED A FOLLOW-UP REPORT WILL BE PROVIDED WHICH WILL INCLUDE THE EVALUATION SUMMARY.

    Description of Event or Problem · 1

    "PT STATES KNEE IS NOT LOCKING AT HEEL STRIKE AND HAS CAUSED HIM TO FALL BREAKING HIS FEMUR AND BEING SURGICALLY REPAIRED. KNEE BUCKLES WHILE HE IS STANDING AND FEELS THAT IT IS USED TO LOCK AT ONE TIME." MAJORITY OF THE TIME PT WALKS WITH MANUAL LOCK ENGAGED AND USES A WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAUCH KNEE ISY OSSUR AMERICAS MKN01360

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention LOCKING GEL LINER WITH A PIN AND LOCK MECHANISM| SILESIAN BELT| COLLEGE PARK TRUE STEP FOOT