BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR PE LINER

    MDR report key: 7206141 · Received January 19, 2018

    Report

    Report Number
    3005180920-2017-00862
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    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 JANUARY 2018. LOT 171736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JULY 2017. EXPIRATION DATE: 2022-07-14. 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 32 SIZE XL +7 CODE 01.25.024 LOT. 091344/T: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 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

    REVISION SURGERY PERFORMED 2 MONTHS AFTER PRIMARY DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND SWAPPED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49519 MPACT ACETABULAR PE LINER ACETABULAR FIXED PE LINER LPH MEDACTA INTERNATIONAL SA 171736 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention