BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 21354696 · Received February 11, 2025

    Report

    Report Number
    3005180920-2025-00076
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    January 22, 2025
    Report Date
    February 11, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    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 29-JAN-2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2024. EXPIRATION DATE: 19-FEB-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 IMPLANTS REVISED: BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 (K112115) LOT. 2407933. BATCH REVIEW PERFORMED ON 29-JAN-2025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2024. EXPIRATION DATE: 27-MAR-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. CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52 (K143453) LOT. 2346409, BATCH REVIEW PERFORMED ON 29-JAN-2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2024. EXPIRATION DATE: 22-MAY-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. SMS SOLID 01.36.043 SMS SOLID STEM STD SIZE 3 (K181693) LOT. 2104518, BATCH REVIEW PERFORMED ON 29-JAN-2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2021. EXPIRATION DATE: 22-JUL-2026. 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

    AT ABOUT 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING GROWING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684596 DOUBLE MOBILITY LINER VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 52/28 MEH MEDACTA INTERNATIONAL SA 01.26.2852MHC 2349499 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention