BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PYROCARBON IMPLANT

    MDR report key: 20393634 · Received October 8, 2024

    Report

    Report Number
    3000931034-2024-00603
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    January 1, 2022
    Report Date
    October 8, 2024
    Manufacturer
    TORNIER S.A.S.
    Product Code
    QKW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    AS REPORTED: "SUBJECT (B)(6): PYC STUDY. CREPITATION WITH PAIN (INCLUDING SQUEAKING)/ PAIN WITH EXTREME RANGE OF MOTION, ALSO SOME CREPITATION. TESTING FOR POSSIBILITY OF INFECTION: LABS, MRI, CT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248232 UNKNOWN PYROCARBON IMPLANT SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEM OR UNCEM QKW TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other