BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR BALL HEAD 12/14 Ø 28 SIZE XL +7

    MDR report key: 7522290 · Received May 17, 2018

    Report

    Report Number
    3005180920-2018-00338
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030805134
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 MAY 2018; LOT 145715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 OCTOBER 2014. EXPIRATION DATE: 2019-09-30; 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; MPACT DM DOUBLE MOBILITY HC LINER 28/DMG REFERENCE 01.26.2854MHC (K092265); LOT 174324: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 NOVEMBER 2017. EXPIRATION DATE: 2022-11-06; 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 DUE TO SIGNS OF INFECTION AFTER 2 MONTHS. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365006 COCR BALL HEAD 12/14 Ø 28 SIZE XL +7 COCR BALL HEAD JDI MEDACTA INTERNATIONAL SA 145715 07630030805134

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention