BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECATCER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 6263426 · Received January 19, 2017

    Report

    Report Number
    3005180920-2016-00751
    Event Type
    Injury
    Date Received
    January 19, 2017
    Date of Event
    December 20, 2016
    Report Date
    January 19, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 28 DECEMBER 2016 AND INCLUDES: THE PATHOGEN RESULTS ARE NOT AVAILABLE YET. BATCH REVIEW PERFORMED ON 17 JANUARY 2017. LOT 163457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-23. 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 SURGEON SUSPECTED THE PATIENT HAD AN INFECTION, SO HE PERFORMED A WASH OUT AND REPLACED THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48329 MECATCER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 163457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention