BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 8045566 · Received November 7, 2018

    Report

    Report Number
    3005180920-2018-00869
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 7, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 NOVEMBER 2018. LOT 180756: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JUNE 2018. EXPIRATION DATE: 2023-05-23. 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.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON THE SAME DAY OF PRIMARY SURGERY DUE TO PROXIMAL FEMORAL FRACTURE. THE FRACTURE WAS DISCOVERED AFTER PRIMARY SO A REVISION WAS NECESSARY. AMISTEM-H STEM WAS REPLACED WITH THE CEMENTED STEM. THE REASON FOR BONE FRACTURE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887631 AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 180756 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention