BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER 36/E

    MDR report key: 11138872 · Received January 8, 2021

    Report

    Report Number
    3005180920-2021-00017
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: LOT 2006537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-SEPTEMBER-2020. EXPIRATION DATE: 2025-08-25. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 21 DECEMBER 2020: BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 (K112115)LOT. 1910896. LOT 1910896: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APRIL-2020. EXPIRATION DATE: 2025-04-08. 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND INSERT, 1 MONTH AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39159 LINER: MPACT FLAT PE HC LINER 36/E LINER: FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 01.32.3644HCT 2006537 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention