BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE L

    MDR report key: 9870997 · Received March 24, 2020

    Report

    Report Number
    3005180920-2020-00187
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    March 9, 2018
    Report Date
    March 24, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    PMA / PMN Number
    K112115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 9 MARCH 2020: LOT 174723: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-DEC-2017. EXPIRATION DATE: 2022-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 9 MARCH 2020: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F ((B)(4)) LOT 174334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-NOV-2017. EXPIRATION DATE: 2022-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 1 YEAR AND 11 MONTHS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335509 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.210 174723 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention