BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR REAMER 57MM HEX

    MDR report key: 8903129 · Received August 16, 2019

    Report

    Report Number
    3010536692-2019-01007
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    June 3, 2019
    Report Date
    August 16, 2019
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HWE
    UDI-DI
    M684SPTHRM571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY THERE IS OXIDATION/RUSTY ON THE REAMER SURFACE, ESPECIALLY CLOSE TO THE LASER MARKING. SURGERY WAS EXTENDED GREATER THAN 30 MINUTES. KIT NUMBER: SPRMKIT1. KIT LOT NUMBER: G161553.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695031 ACETABULAR REAMER 57MM HEX HIP INSTRUMENT HWE MICROPORT ORTHOPEDICS INC. SPTHRM57 1325944 M684SPTHRM571

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention