BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 22539991 · Received July 18, 2025

    Report

    Report Number
    3005180920-2025-00695
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807282
    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 10 JULY 2025. LINER: MPACT 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø28/DME (K092265) LOT. 1907478: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2019. EXPIRATION DATE: 18-SEPT-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: CUP: MPACT 01.32.150MB MPACT DM ACETABULAR SHELL Ø50 (K143453) LOT. 1907408: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2020. EXPIRATION DATE: 2025-JAN-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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

    AT ABOUT 4 YEARS 11 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE CUP. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER TO SEMI-COSTRAINED, THE HEAD TO ANOTHER MEDACTA HEAD AND THE CUP TO A COMPETITOR'S. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808374 DOUBLE MOBILITY LINER LINER: MPACT 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø28/DME MEH MEDACTA INTERNATIONAL SA 01.26.2850MHC 1907478 07630030807282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention