BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX ABC CE MARK 1 PCK

    MDR report key: 17610043 · Received August 24, 2023

    Report

    Report Number
    0002249697-2023-00932
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    December 18, 2014
    Report Date
    August 24, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AS REPORTED VIA MW5119538: CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AT 3 MONTHS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. (PER THE MEDWATCH REPORT PROVIDING A DATE OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310749 SIMPLEX ABC CE MARK 1 PCK BONE CEMENT, ANTIBIOTIC MBB STRYKER ORTHOPAEDICS-MAHWAH BHV027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R