BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8217185 · Received January 4, 2019

    Report

    Report Number
    3005180920-2018-01057
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 5, 2018
    Report Date
    January 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 JANUARY 2019: LOT 179836: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 JUNE 2018. EXPIRATION DATE: 2023-05-31. 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. MPACT FLAT PE HC LINER Ø32/D, REFERENCE 01.32.3241HCT (K103721): LOT 182608: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 JULY 2018. EXPIRATION DATE: 2023-06-19. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 3 WEEKS AFTER THE PRIMARY SURGERY (PATHOGEN UNKNOWN). THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12208 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 179836 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention