BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEO KNEE

    MDR report key: 2072658 · Received April 21, 2011

    Report

    Report Number
    3026585-2011-00003
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 20, 2011
    Manufacturer
    OSSUR
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE PT AND THE TREATING PHYSICIAN INDICATE THAT THE INJURY WAS THE RESULT OF A FALL BY THE PT, AND THE PRODUCT WAS NOT AT FAULT.

    Description of Event or Problem · 1

    PT WEARING A PROSTHETIC RHEO KNEE PRODUCT FELL AND TORE HER ROTATOR CUFF WHICH REQUIRED SURGERY. BOTH THE PT AND THE TREATING PHYSICIAN STATED THE PRODUCT DID NOT FAIL AND THE INJURY WAS NOT CAUSED BY THE PRODUCT, BUT WAS UNRELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEO KNEE IQI OSSUR RKN100007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention