BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6

    MDR report key: 11200885 · Received January 20, 2021

    Report

    Report Number
    3005180920-2021-00054
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 20, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885662
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 JANUARY 2021: LOT 163570: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JULY-2016. EXPIRATION DATE: 2021-07-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. ANOTHER SIMILAR EVENT HAS BEEN REPORTED. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 18 JANUARY 2021: CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50 (K143453)LOT. 160428: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APRIL-2016. EXPIRATION DATE: 2021-03-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO STEM LOOSENING, 4 YEARS 4 MONTHS AFTER THE PRIMARY. TESTS SHOWED THAT THE PATIENT HAD AN ALLERGIC REACTION TO NICKEL. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97170 STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6 STEM CEMENTLESS TI COATED LZO MEDACTA INTERNATIONAL SA 01.39.206 163570 07630030885662

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention