BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P STD SIZE 4

    MDR report key: 11045448 · Received December 21, 2020

    Report

    Report Number
    3005180920-2020-00950
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    November 28, 2020
    Report Date
    December 21, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720038
    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 09 DECEMBER 2020: LOT 1903224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2019. EXPIRATION DATE: 2024-07-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 09 DECEMBER 2020: BALL HEADS: BIPOLAR HEAD 25060.2848 BIPOLAR HEAD Ø28X48 (K091967) LOT 1811800: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAY-2019. EXPIRATION DATE: 2024-05-01. 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. BALL HEADS: COCR 01.25.011 COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K072857) LOT 1910795: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2020. EXPIRATION DATE: 2025-04-01. 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

    REVISION SURGERY FOR HIP INFECTION 3 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516183 STEM: AMISTEM P STD SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 1903224 07630040720038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention