BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE 2100

    MDR report key: 10655463 · Received October 9, 2020

    Report

    Report Number
    0001836248-2020-00003
    Event Type
    Injury
    Date Received
    October 9, 2020
    Report Date
    May 26, 2021
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIALLY THE MANUFACTURER WAS INFORMED THAT THE PROSTHETIC KNEE WAS BUCKLING AND THE PATIENT MIGHT HAVE FALLEN BUT NO INFORMATION WERE GIVEN REGARDING ANY INJURIES. AFTER SEVERAL ATTEMPTS CONTACTING THE CLINIC THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAD BEEN INJURED AND HAD TO BE HOSPITALIZED.

    Description of Event or Problem · 0

    USER FELL WHEN USING HIS PROSTHETIC KNEE. USER EXPERIENCED SERIOUS INJURIES AS HE INJURED HIS HIP AND NEEDED TO UNDERGO A SURGERY.

    Additional Manufacturer Narrative · 1

    INITIALLY THE MANUFACTURER WAS INFORMED THAT THE PROSTHETIC KNEE WAS BUCKLING AND THE PATIENT MIGHT HAVE FALLEN BUT NO INFORMATION WERE GIVEN REGARDING ANY INJURIES. AFTER SEVERAL ATTEMPTS CONTACTING THE CLINIC THE MANUFACTURER WAS INFORMED THAT THE PATIENT HAD BEEN INJURED AND HAD TO BE HOSPITALIZED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    PROSTHETIC KNEE WAS BUCKLING AND THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118685 TOTAL KNEE 2100 PROSTHETIC KNEE ISY OSSUR AMERICAS 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization