BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H COATED STD STEM SIZE 1

    MDR report key: 12859341 · Received November 23, 2021

    Report

    Report Number
    3005180920-2021-00939
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 NOVEMBER 2021: LOT 173487: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2017. EXPIRATION DATE: 2022-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD. PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: DURING THE ANALYSIS IT IS EVALUATED THAT THE HA ON THE STEM BODY HAS BEEN COMPLETELY ABSORBED BY PATIENT BONE AS EXPECTED. SOME SIGNS AND SCRATCHES ARE PRESENT ON THE NECK PART PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED STEM LOOSENING.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO STEM LOOSENING, THE STEM HAD AND LINER WERE REVISED. THE EXACT PRIMARY DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757963 AMISTEM H COATED STD STEM SIZE 1 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.131 173487 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention