BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5973236 · Received September 23, 2016

    Report

    Report Number
    3005180920-2016-00486
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 23, 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 REVIEW PERFORMED ON (B)(6) 2016. LOT 150453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-05-31. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE FEMORAL HEAD WAS REMOVED AND REPLACED. THIS SURGERY WAS PERFORMED BECAUSE OF A LEG LENGTH DISCREPANCY WHICH THE SURGEON DEEMED UNSATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625096 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M 0 CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 150453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention