BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM P STD STEM SIZE 4

    MDR report key: 11093712 · Received December 30, 2020

    Report

    Report Number
    3005180920-2020-00962
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    November 2, 2020
    Report Date
    February 19, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720038
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DEPARTMENT: POSTOPERATIVE FEMORAL FRACTURE, ONE YEAR AND 8 MONTHS AFTER PRIMARY CEMENTLESS THA. THE FRACTURE IS DUE TO A TRAUMATIC EVENT. NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2020. LOT 182528: 100 ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2018. EXPIRATION DATE: 2023-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 97 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVEN

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AND 8 MONTHS AFTER PRIMARY SURGERY, DUE TO A BROKEN FEMUR. STEM, BALL HEAD AND BIPOLAR HEAD HAVE BEEN SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562968 STEM: AMISTEM P STD STEM SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 182528 07630040720038

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention