BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 21825184 · Received April 11, 2025

    Report

    Report Number
    3005180920-2025-00292
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 11, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    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 26 MARCH 2025: LOT 2347552: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20/02/2024. EXPIRATION DATE: 05/02/2029. 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 IMPLANT REVISED: BATCH REVIEW PERFORMED ON 26 MARCH 2025 ON BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 2414769 LOT 2414769: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10/06/2024. EXPIRATION DATE: 23/05/2029. 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. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN. REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE HEAD FROM THE DOUBLE MOBILITY LINER (INTRA-PROSTHETIC DISLOCATION). ABOUT 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON HAD TO REVISE THE CUP BECAUSE A SEMI CONSTRAINED LINER IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104175 DOUBLE MOBILITY LINER LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28 MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2347552

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention