BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC Ø40/F

    MDR report key: 12851445 · Received November 22, 2021

    Report

    Report Number
    3005180920-2021-00897
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 24, 2021
    Report Date
    November 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030812262
    PMA / PMN Number
    K122641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 OCTOBER 2021: LOT 2100164: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2021. EXPIRATION DATE: 2026-01-20. 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. ANOTHER DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 28 OCTOBER 2021: BALL HEADS: MECTACER 01.29.215 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8 (K112115). LOT 189656: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2019. EXPIRATION DATE: 2024-01-22. 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 · 0

    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 1 MONTH AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749044 LINER: MPACT FLAT PE HC Ø40/F ACETABULAR LINER LZO MEDACTA INTERNATIONAL SA 01.32.4048HCT 2100164 07630030812262

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention