BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE3

    MDR report key: 8256608 · Received January 17, 2019

    Report

    Report Number
    3005180920-2018-01117
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    December 21, 2018
    Report Date
    January 17, 2019
    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 · 1

    BATCH REVIEW PERFORMED ON 17 JANUARY 2019: LOT 133059: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2013. EXPIRATION DATE: 2018-08-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 5 YEARS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY A LOOSE STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51123 STEM: AMISTEM H HA COATED STD STEM SIZE3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 133059 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention