BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M

    MDR report key: 10475977 · Received September 1, 2020

    Report

    Report Number
    3005180920-2020-00545
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809132
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 AUGUST 2020: LOT 1906462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2019. EXPIRATION DATE: 2024-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 4 OTHER SIMILAR EVENTS REPORTED ON THE LOT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 13 AUGUST 2020: LINER: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT 1910313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2020. EXPIRATION DATE: 2025-02-03. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 1 MONTH AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943704 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.202 1906462 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention