BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/E

    MDR report key: 7968833 · Received October 16, 2018

    Report

    Report Number
    3005180920-2018-00796
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812118
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 OCTOBER 2018; LOT 181816: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JUNE 2018. EXPIRATION DATE: 2023-05-27; 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. COCR BALL HEAD 12/14 Ø 36 SIZE M REFERENCE 01.25.031 (K080885); LOT 180329: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 APRIL 2017. EXPIRATION DATE: 2023-04-10; 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 INFECTION 2 WEEKS AFTER THE PRIMARY. THE PATIENT WAS POSITIVE FOR PUS BUT THE INFECTION HAS NOT BEEN IDENTIFIED YET. THE SURGEON PERFORMED A WASH OUT THEN REMOVED AND REPLACED THE POLY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. UPDATE 27 SEPTEMBER 2018: PATHOGEN NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809245 MPACT FLAT PE HC LINER Ø36/E FLAT PE HC LINER LPH MEDACTA INTERNATIONAL SA 181816 07630030812118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention