BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0

    MDR report key: 11848921 · Received May 19, 2021

    Report

    Report Number
    3005180920-2021-00399
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040719995
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 APRIL 2021: LOT 1811092: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-APR-2019. EXPIRATION DATE: 2024-03-25. 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. ADDITIONAL ITEM INVOLVED IN THE EVENT: BALL HEADS: COCR 01.25.021 COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5 (K072857) LOT. 1905318 BATCH REVIEW PERFORMED ON 30 APRIL 2021: LOT 1905318: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-NOV-2019. EXPIRATION DATE: 2024-11-11. 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

    11 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT HAD A 1.5CM TOO LONG LEG, THEREFORE THE SURGEON DECIDED TO REMOVE THE STEM AND TO PUT A NEW ONE, TRYING TO SHORTEN THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745496 STEM: AMISTEM P AMISTEM-P STD STEM SIZE 0 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1811092 07630040719995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention