BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø 32 / D

    MDR report key: 6141273 · Received December 2, 2016

    Report

    Report Number
    3005180920-2016-00629
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 25 NOVEMBER 2016. LOT 132126: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4, CODE 01.29.204, LOT. 161053 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 MAY 2016. EXPIRATION DATE: 2021-04-28. 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. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION IS CONFIRMED. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I & D AND SWAPPED OUT THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793184 MPACT FLAT PE HC LINER Ø 32 / D FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 132126

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention