BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 7259389 · Received February 9, 2018

    Report

    Report Number
    3005180920-2018-00032
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    December 11, 2017
    Report Date
    January 12, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030812132
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 FEBRUARY 2018. LOT 170131: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 MARCH 2017. EXPIRATION DATE: 2022-03-09 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 (K112115), LOT 174711: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 OCTOBER 2017. EXPIRATION DATE:2022-09-28 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. THE PATHOGEN WILL NOT BE AVAILABLE. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104431 LINER: MPACT FLAT PE HC LINER Ø36/F FLAT HIP LINER LPH MEDACTA INTERNATIONAL SA 170131 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention