BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 25039783 · Received April 30, 2026

    Report

    Report Number
    3005180920-2026-00374
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 30, 2026
    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 APR 2026 LINER: VERSACEM 01.26.2848MHC DOUBLE MOBILITY HC LINER D 28/DMD (K092265) LOT: 2429853: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2024. EXPIRATION DATE: 05-DEC-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. BALL HEADS: COCR 01.25.015 COCR BALL HEAD 12/14 D 28 MM SIZE XXL (K072857) LOT. 2246984: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-FEB-2023. EXPIRATION DATE: 12-FEB-2028. 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. CUP: VERSACEM 01.27.48CMB VERSACEM METALBACK D 48 MM (K241767) LOT. 2415688: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2024. EXPIRATION DATE: 23-OCT-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.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO DISSOCIATION OF DM LINER FROM THE METAL FEMORAL HEAD AND DISLOCATION OF DM LINER FROM THE VERSACEM CUP AT 6 WEEKS FROM PRIMARY. LINER AND HEAD REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138268 DOUBLE MOBILITY LINER DOUBLE MOBILITY HC LINER Ø28/DMD MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 2429853 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention