BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0

    MDR report key: 6106005 · Received November 16, 2016

    Report

    Report Number
    3005180920-2016-00589
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 16, 2016
    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

    BATCH REVIEWS PERFORMED ON 14 NOVEMBER 2016. LOT 161744: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MAY 2016. EXPIRATION DATE: 2021-04-27. 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 FLAT PE HC LINER Ø 32 / E, CODE 01.26.3244HCT, LOT. 146005 (K103352), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 OCTOBER 2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 WOUND ISSUES. SWAB AND SAMPLES WERE TAKEN FOR TESTING. RESULTS SHOWED PSEUDOMONAS INFECTION. THE LINER AND THE BALL HEAD WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756908 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 161744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention