BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE M 0

    MDR report key: 7540695 · Received May 24, 2018

    Report

    Report Number
    3005180920-2018-00356
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 24, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805110
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 MAY 2018. LOT 176024: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 DECEMBER 2017. EXPIRATION DATE: 2022-11-16 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. VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28 REFERENCE 01.26.2852MHC (K092265) LOT 177528: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 FEBRUARY 2018. EXPIRATION DATE: 2023-02-04 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 DUE TO SIGNS OF INFECTION 2 WEEKS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385732 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 176024 07630030805110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention