BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STD STEM SIZE 5

    MDR report key: 12438435 · Received September 8, 2021

    Report

    Report Number
    3005180920-2021-00343
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    March 31, 2021
    Report Date
    September 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804304
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12.04.2021: LOT 180031: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CORRECTED DATA: ON THE 27 APRIL 2021 THIS MDR WAS SENT TO THE FDA TEST WEBTRADER (HTTPS://ESGTEST.FDA.GOV) FOR ERROR. TODAY 9 SEPTEMBER 2021 WE RECONGNIZED THE ERROR AND SENT THE MDR TO FDA PRODUCTION WEBTRADER (HTTPS://ESG.FDA.GOV).

    Description of Event or Problem · 1

    2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR STEM AND HEAD, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336562 AMISTEM C CEMENTED STD STEM SIZE 5 HIP CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.18.155 180031 07630030804304

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention