BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 21292462 · Received February 3, 2025

    Report

    Report Number
    3005180920-2025-00024
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    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 16-01-2024: LOT 2411631: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-05-2024. EXPIRATION DATE: 2029-05-14. 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 IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 16-01-2024: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT 2422242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-09-2024. EXPIRATION DATE: 2029-08-19. 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: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50 (K143453) LOT 2403427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-07-2024. EXPIRATION DATE: 2029-07-08. 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. STEM: SMS SOLID 01.36.068 SMS SOLID STEM LAT SIZE 8 (K181693) LOT 2246309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-03-2023. EXPIRATION DATE: 2028-03-12. 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

    AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294847 DOUBLE MOBILITY LINER HC PE LINER 28 / DME MEH MEDACTA INTERNATIONAL SA 01.26.2850MHC 2411631 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention