BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 14369188 · Received May 12, 2022

    Report

    Report Number
    3005180920-2022-00358
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 APRIL 2022: LOT 133951: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 19 APRIL 2022: BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 (K112115) LOT. 113148 LOT 113148: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2011. EXPIRATION DATE: 2016-09-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING THIGH PAIN AND THE CAUSE IS UNKNOWN. AT 8 YEARS AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132191 STEM: AMISTEM H HA COATED STD STEM SIZE 3 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.133 133951 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention