BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHEO KNEE

    MDR report key: 801432 · Received December 27, 2006

    Report

    Report Number
    1836248-2006-00004
    Event Type
    Injury
    Date Received
    December 27, 2006
    Date of Event
    November 23, 2006
    Report Date
    November 30, 2006
    Manufacturer
    OSSUR H/F
    Product Code
    ISW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: AN ATTEMPT WILL BE MADE TO IDENTIFY OR POSSIBLY ACQUIRE THE ADAPTER USED AT THE PROXIMAL ATTACHMENT POINT OF THE KNEE. THIS WILL ALLOW A MORE ACCURATE EVAL. IF WE ARE SUCCESSFUL, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    "PT WAS GETTING OUT OF HIS TRUCK, PYRAMID TWISTED OFF RHEO KNEE, PT FELL DOWN AND HIT HIS HEAD ON HIS BUMPER." STATED INJURY "PT HAS A FRACTURED WRIST (TWO PLACES), HURT HIS LOWER BACK AND HIT HIS HEAD." PT SOUGHT TREATMENT IN 06. DIAGNOSIS OF DISTAL RADIUS FRACTURE, BACK STRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHEO KNEE ISW ISW OSSUR H/F RKN10000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention