BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT HOODED PE HC LINER Ø36/E

    MDR report key: 7185481 · Received January 12, 2018

    Report

    Report Number
    3005180920-2017-00837
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    December 14, 2017
    Report Date
    January 12, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812101
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JANUARY 2018 LOT 166692: (B)(4) TEMS MANUFACTURED AND RELEASED ON 25 NOVEMBER 2016. EXPIRATION DATE: 2021-11-08 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 COMPLAINED HIP INSTABILITY. THE SURGEON REVISED THE PATIENT SWAPPING SUCCESSFULLY THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31547 MPACT HOODED PE HC LINER Ø36/E HOODED LINER FOR HIP LPH MEDACTA INTERNATIONAL SA 166692 07630030812101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention