BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0

    MDR report key: 10217851 · Received July 1, 2020

    Report

    Report Number
    3005180920-2020-00367
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804069
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 12 JUNE 2020: LOT 150839: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2015. EXPIRATION DATE: 2020-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING THIGH PAIN AFTER 4 YEARS AND 4 MONTHS FROM THE PRIMARY DUE TO STEM LOOSENING (PROXIMALLY) AND POTTED (DISTALLY). THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT 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
    681639 STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.130 150839 07630030804069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention