BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 23837297 · Received December 18, 2025

    Report

    Report Number
    3005180920-2025-01251
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 DECEMBER 2025: LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER D 28/DMD (K092265) LOT 145385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 D 28 MM SIZE M (K072857) LOT 161449: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-APRIL-2016. EXPIRATION DATE: 2021-03-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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

    AT ABOUT 9 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618617 DOUBLE MOBILITY LINER DOUBLE MOBILITY HC LINER Ø28/DMD MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 145385 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention