BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATOR COOL POST OP KNEE

    MDR report key: 5648783 · Received May 11, 2016

    Report

    Report Number
    2085446-2016-00003
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    March 11, 2016
    Report Date
    May 5, 2016
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ITQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS PRONE TO KNEE DISLOCATION. NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    PATIENT WITH CHRONIC PATELLA DISLOCATION WITH A HISTORY OF RECURRENT DISLOCATIONS WAS FIT WITH A COOL POST-OP KNEE BRACE WITH FULL EXTENSION BLOCKED. THE PATIENT CLAIMS TO HAVE KNOCKED THE EXTENSION SETTING WHICH ALLOWED THE DIAL TO DISENGAGE AND ALLOW MORE EXTENSION THAN DESIRED. THEY BELIEVE THIS RESULTED IN THE PATIENT RE-DISLOCATING THE PATELLA.

    Description of Event or Problem · 1

    PATIENT WITH CHRONIC PATELLA DISLOCATION WITH A HISTORY OF RECURRENT DISLOCATIONS WAS FIT WITH A COOL POST-OP KNEE BRACE WITH FULL EXTENSION BLOCKED. THE PATIENT CLAIMS TO HAVE KNOCKED THE EXTENSION SETTING WHICH ALLOWED THE DIAL TO DISENGAGE AND ALLOW MORE EXTENSION THAN DESIRED. THEY BELIEVE THIS RESULTED IN THE PATIENT RE-DISLOCATING THE PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303977 INNOVATOR COOL POST OP KNEE JOINT, KNEE, EXTERNAL BRACE ITQ OSSUR AMERICAS 403100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other