BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 14732935 · Received June 17, 2022

    Report

    Report Number
    3005180920-2022-00480
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 24, 2022
    Report Date
    June 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 MAY 2022, LOT 2113568: (B)(4). ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 25 MAY 2022 LINER: IMPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2114161: (B)(4). EXPIRATION DATE: 2026-OCT-11. 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 AND THE PATHOGEN IS UNKNOWN. AT 22 DAYS AFTER THE PRIMARY SURGERY, 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
    193853 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2113568 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention