BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 9503220 · Received December 20, 2019

    Report

    Report Number
    3005180920-2019-01099
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 DECEMBER 2019: LOT 161461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUNE-2016. EXPIRATION DATE: 2021-05-24. 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.

    Description of Event or Problem · 1

    AFTER TAKING X-RAYS THE SURGEON OBSERVED THAT THE PATIENT HAD RADIOLUCENCY'S AROUND THE PROXIMAL AREAS OF THE FEMUR. ABOUT 3 YEARS AFTER PRIMARY THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD, AND LINER. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301511 STEM: AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 161461 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention