BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6

    MDR report key: 8439905 · Received March 21, 2019

    Report

    Report Number
    3005180920-2019-00183
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    February 20, 2019
    Report Date
    March 21, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720052
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 MARCH 2019: LOT 182533: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2018. EXPIRATION DATE: 2023-08-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    AFTER THE PRIMARY HIP SURGERY WAS COMPLETE, IT WAS DISCOVERED THAT THE FEMUR HAD SUSTAINED AN INTRA-OPERATIVE FRACTURE. THE SURGEON SUSPECTS THE FRACTURE OCCURRED WHEN THE STEM WAS IMPLANTED. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM FROM A SIZE 6 TO A SIZE 5 AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233297 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 6 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 182533 07630040720052

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention