BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1

    MDR report key: 11911476 · Received June 1, 2021

    Report

    Report Number
    3005180920-2021-00452
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 3, 2021
    Report Date
    June 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720205
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 MAY 2021: LOT 2009295: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-NOV-2020. EXPIRATION DATE: 2025-11-10. 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, BATCH REVIEW PERFORMED ON 11 MAY 2021: BALL HEADS: MECTACER 01.29.208 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115) LOT. 2002607. LOT 2002607: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUL-2020. EXPIRATION DATE: 2025-07-21. 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

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. 3 DAYS AFTER PRIMARY THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811182 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2009295 07630040720205

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention