BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED HA COATED STD STEM SIZE 4

    MDR report key: 7137933 · Received December 21, 2017

    Report

    Report Number
    3005180920-2017-00762
    Event Type
    Injury
    Date Received
    December 21, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 21, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804595
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 173444: 50 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING SURGERY THE PATIENT'S DISTAL FEMUR FRACTURED. THE SURGEON REMOVED THE MEDACTA STEM AND REPLACED IT WAS ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS DELAYED APPROXIMATELY 3.5 HOURS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918662 AMISTEM COLLARED HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 173444 07630030804595

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention