BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

    MDR report key: 14021621 · Received April 6, 2022

    Report

    Report Number
    3005180920-2022-00227
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 5, 2022
    Report Date
    April 6, 2022
    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 · 0

    BATCH REVIEW PERFORMED ON 04-APR-2022; LOT 2010621: (B)(4). EXPIRATION DATE: 2026-01-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440492 BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.202 2010621 07630030809132

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention