BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM-H PROXIMAL COATING STD STEM SIZE 8

    MDR report key: 7726662 · Received July 27, 2018

    Report

    Report Number
    3005180920-2018-00571
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    July 6, 2018
    Report Date
    July 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804434
    PMA / PMN Number
    K161635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 JULY 2018: LOT 171674: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 AUGUST 2017. EXPIRATION DATE: 2022-08-17. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 1 MONTH AFTER PRIMARY. THE SURGEON DETERMINED THAT THE PATIENT FRACTURED NEAR THE DISTAL END OF THE STEM. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT. THE CUP AND LINER REMAIN IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567696 AMISTEM-H PROXIMAL COATING STD STEM SIZE 8 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 171674 07630030804434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention