BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 7706383 · Received July 20, 2018

    Report

    Report Number
    3005180920-2018-00527
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    June 12, 2018
    Report Date
    June 21, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    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 17 JULY 2018; LOT 173488: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 NOVEMBER 2017. EXPIRATION DATE: 2022-10-30. 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

    NINE DAYS AFTER PRIMARY THE PATIENT SAT DOWN AND HEARD A POP. THE SURGEON DETECTED A FEMORAL FRACTURE AND SWAPPED SUCCESSFULLY STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548735 AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 173488 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention