MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; DOUBLE MOBILITY HC LINER Ø28/DMI

Model Number	01.26.2858MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient had primary right hip surgery.On (b)(6) 2023, the patient came in reporting pain due to a periprosthetic fracture that was caused from falling.The surgeon cabled the fracture, revised the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully on (b)(6) 2025, the patient came in due to pain and the cause is unknown.The surgeon revised the competitor stem and head with a competitor stem and head and revised the medacta liner with a medacta liner.The case was completed successfully.On (b)(6) 2025, the patient came in due to pain associated with a dislocation.The surgeon swapped the dm liner.The surgery was completed successfully.Presently, on (b)(6) 2025, the patient came in due to pain associated with a dislocation of the head from the liner and the cause is unknown.The surgeon swapped the liner with competitor`s liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 dec 2025.Liner: mpact dm 01.26.2858mhc double mobility hc liner d 28/dmi (k092265) lot 2105783: (b)(4) items manufactured and released on 18-jun-2021.Expiration date: 09-jun-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.Cup: mpact 01.32.158mb mpact dm acetabular shell d 58 (k143453) lot.2218082: (b)(4) items manufactured and released on 26-jan-2023.Expiration date: 11-jan-2028.No anomalies found related to the problem.To date, all items of the same lot have been sold with one similar reported event during the period of review (the previous event is related to the same patient).Root cause: 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.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: DOUBLE MOBILITY HC LINER Ø28/DMI
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23836920
• Report Number: 3005180920-2025-01260
• Device Sequence Number: 5081108
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• Combination Product (Y/N): N
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2026
• Device Model Number: 01.26.2858MHC
• Device Lot Number: 2105783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown