BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28

    MDR report key: 13415525 · Received February 1, 2022

    Report

    Report Number
    3005180920-2022-00058
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    January 5, 2022
    Report Date
    February 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807442
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JANUARY 2022: LOT 2010829: (B)(4). EXPIRATION DATE: 2025-11-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 31 JANUARY 2022: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 2011654: (B)(4). EXPIRATION DATE: 2026-02-11. 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. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504219 VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 58/28 HIP DOUBLE MOBILITY LINER LZO MEDACTA INTERNATIONAL SA 01.26.2858MHC 2010829 07630030807442

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention