BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 22157481 · Received June 6, 2025

    Report

    Report Number
    3005180920-2025-00540
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    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 26 MAY 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21/05/2024. EXPIRATION DATE: 06/05/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: BALL HEADS: MECTACER 01.29.201 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S (K112115) LOT. 2435423 BATCH REVIEW PERFORMED ON 26 MAY 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15/01/2025. EXPIRATION DATE: 12/12/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 WEEK 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
    1493419 DOUBLE MOBILITY LINER VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 52/28 MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 2409372 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention