BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø36/F

    MDR report key: 7281212 · Received February 19, 2018

    Report

    Report Number
    3005180920-2018-00061
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    January 21, 2018
    Report Date
    February 19, 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 19 FEBRUARY 2018. LOT 140554: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08 APRIL 2014. EXPIRATION DATE: 2019-02-28; 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 REFERENCE 01.29.209 (K112115) LOT 150457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 APRIL 2015. EXPIRATION DATE: 2020-03-31; 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

    TWO YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. THE SURGEON PERFORMED AN I&D AND SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124055 MPACT FLAT PE HC LINER Ø36/F LINER PE HC LPH MEDACTA INTERNATIONAL SA 140554 07630030812132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention