BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 21762531 · Received April 3, 2025

    Report

    Report Number
    3005180920-2025-00255
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 MARCH 2025 LOT 2422027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21/10/2024. EXPIRATION DATE: 01/10/2029. 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. OTHER DEVICE INVOLVED: BALL HEADS: MECTACER 01.29.230H HEAD BIOLOX OPTION Ø 28 (K131518) LOT 2427936: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24/10/2024. EXPIRATION DATE: 07/10/2029. 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 HAD A PRIMARY HIP SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. 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
    1459701 DOUBLE MOBILITY LINER LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø28/DMG MEH MEDACTA INTERNATIONAL SA 01.26.2854MHC 2422027 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention