BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD SIZE 0

    MDR report key: 12758266 · Received November 7, 2021

    Report

    Report Number
    3005180920-2021-00849
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804250
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2021. LOT 2012715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-FEB-2021. EXPIRATION DATE: 2026-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: DURING PRIMARY THA SURGERY, WHILE THE CEMENTED STEM WAS BEING INSERTED, THE SURGEON NOTICED A BONE FRACTURE AND PROCEEDED TO APPLY CERCLAGE. THIS SHOULD NOT HAVE ADVERSE CONSEQUENCES. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    WHEN INSERTING THE STEM, THE SURGEON NOTICED A FRACTURE AROUND THE STEM. HE WRAPPED THE CABLE AROUND THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THE CAUSE MAY BE OVER-INSERTION OF STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659833 STEM: AMISTEM C CEMENTED STD SIZE 0 CEMENTED FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 01.18.150 2012715 07630030804250

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other