BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3

    MDR report key: 17698264 · Received September 7, 2023

    Report

    Report Number
    3005180920-2023-00707
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720229
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-AUG-2023 LOT 2248864: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2023. EXPIRATION DATE: 2028-04-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 24-AUG-2023. STEM: AMISTEM P 01.18.403 AMISTEM-P STD STEM SIZE 3 (K173794) LOT. 2246931 LOT 2246931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2023. EXPIRATION DATE: 2028-02-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING THE PRIMARY HIP SURGERY, IT WAS OBSERVED THAT THE PATIENT HAD SUSTAINED AN INTRA-OP FRACTURE. IT IS UNKNOWN AT WHICH POINT OF THE SURGERY THE FRACTURE OCCURRED. THE SURGEON BROACHED SEQUENTIALLY TO THE 3. A NON-COLLARED AMISTEM WAS IMPLANTED BUT IT SAT LOWER THAN EXPECTED. THEREFORE, IT WAS EXPLANTED (NO FRACTURES OCCUR) AND A COLLAR STEM WAS IMPLANTED. THE HIP REDUCED AND EASILY DISLOCATED. THE SECOND AMISTEM WAS REMOVED, AND USING A COBB, THE SURGEON LOCATED THE FRACTURE ON THE FEMUR LATERALLY. FINALLY, A COMPETITOR STEM WAS IMPLANTED. THERE WAS NO DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090771 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 2248864 07630040720229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention