BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7178496 · Received January 10, 2018

    Report

    Report Number
    3005180920-2017-00819
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    December 13, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 JANUARY 2018: LOT 164224: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 OCTOBER 2016. EXPIRATION DATE: 2021-10-02. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, 115 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH (B)(4) SIMILAR REPORTED EVENT. MECTACER CERAMIC LINER Ø 36 / F REFERENCE 01.29.414 (NOT MARKETED IN US) LOT. 163509: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-24. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT

    Description of Event or Problem · 1

    ON (B)(4) 2017 MEDACTA SALES RAPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2017 DUE TO INFECTION 8 MONTHS AFTER PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21403 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 164224 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention