BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 5 LOT. 133067

    MDR report key: 12545370 · Received September 29, 2021

    Report

    Report Number
    3005180920-2021-00779
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 29, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804113
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 SEPTEMBER 2021: LOT 133067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-OCT-2013. EXPIRATION DATE: 2018-AUG-31. 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 SINCE 2017.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION 7 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442849 AMISTEM H HA COATED STD STEM SIZE 5 LOT. 133067 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.135 133067 07630030804113

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention