BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 2

    MDR report key: 8178709 · Received December 19, 2018

    Report

    Report Number
    3005180920-2018-01015
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030815751
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2018: LOT 130672: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MAY 2013. EXPIRATION DATE: 2018-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE 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, DUE TO INSTABILITY CAUSED BY A STEM LOOSENING. THE SURGEON REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019452 AMISTEM H HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 130672 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention