BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY HC LINER 28/DME

    MDR report key: 7494719 · Received May 8, 2018

    Report

    Report Number
    3005180920-2018-00305
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 8, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 MAY 2018; LOT 176080 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 DECEMBER 2017. EXPIRATION DATE: 2022-12-03. 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 REFERENCE 01.29.202 (K112115) BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0, LOT 173281: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 OCTOBER 2017. EXPIRATION DATE:2022-10-01. 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 1 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338712 MPACT DOUBLE MOBILITY HC LINER 28/DME DOUBLE MOBILITY LINER MEH MEDACTA INTERNATIONAL SA 176080 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention