BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 8098807 · Received November 22, 2018

    Report

    Report Number
    3005180920-2018-00930
    Event Type
    Injury
    Date Received
    November 22, 2018
    Date of Event
    October 23, 2018
    Report Date
    November 22, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811913
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22 NOVEMBER 2018; LOT 162403: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 JULY 2016. EXPIRATION DATE: 2021-06-30. 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

    ABOUT 5 MONTHS AFTER PRIMARY THE PATIENT CAME IN DUE TO INSTABILITY: THE PATIENT WAS FOUND TO HAVE A DISLOCATION (HEAD FROM LINER). THE SURGEON SWAPPED THE LINER THROUGH POSTERIOR APPROACH: THE NEW LINER IMPLANTED WAS 01.32.3644HCAT, MPACT HOODED LINER HC 36/E, LOT 172564. THE REVISION WAS SUCCESSFUL. THE PRIMARY SURGERY WAS PERFORMED USING AN ANTERIOR APPROACH (AMIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937988 LINER: MPACT FLAT PE HC LINER Ø32/E HIP LINER HC LPH MEDACTA INTERNATIONAL SA 162403 07630030811913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention