BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED STD STEM SIZE 2

    MDR report key: 15536926 · Received October 4, 2022

    Report

    Report Number
    3005180920-2022-00740
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    September 5, 2022
    Report Date
    October 4, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720212
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-SEP-2022: LOT 2011562: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2021. EXPIRATION DATE: 2026-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: BALL HEADS: MECTACER 01.29.204 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 (K112115) LOT. 2009390: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2021. EXPIRATION DATE: 2026-01-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855938 STEM: AMISTEM-P COLLARED STD STEM SIZE 2 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.432 2011562 07630040720212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention