BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 20756050 · Received November 22, 2024

    Report

    Report Number
    3005180920-2024-00967
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    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 04 NOVEMBER 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2020. EXPIRATION DATE: 2025-01-11. 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 INVOLVED: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 2012906. BATCH REVIEW PERFORMED ON 04 NOVEMBER 2024 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2021. EXPIRATION DATE: 2026-01-11. 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. ROOT CAUSE: 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 REPORTED INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. AT 24 DAYS FROM PRIMARY, THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800244 DOUBLE MOBILITY LINER VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 48/28 MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2008277 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention