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	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 dec 2025.Liner: mpact dm 01.26.2858mhc double mobility hc liner d 28/dmi (k092265) lot.2114157: (b)(4) items manufactured and released on 10 nov 2021.Expiration date: 26 oct 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 26/01/2023.Expiration date: 11 jan 2028.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: the root cause of the joint dislocation could not be clearly identified.There is no indication that any device-related issue contributed to the event, and a review of the device history record revealed no potential manufacturing defects.The patient underwent multiple revision surgeries due to falls, periprosthetic fractures, pain, and known joint dislocation, which further confirms the complexity of this case.
Event or Problem Description
On (b)(6) 2023, the patient underwent primary surgery.On (b)(6) 2023, the patient returned reporting pain due to a periprosthetic fracture sustained after a fall.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 presented with pain of unknown cause.The surgeon revised the competitor stem and head with competitor components and revised the medacta liner with a medacta liner.The case was completed successfully.Presently, on (b)(6) 2025, the patient returned with pain associated with a dislocation of the dm liner from the dm cup.The surgeon replaced the dm liner and head.The surgery was completed successfully.

• 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: 23725622
• Report Number: 3005180920-2025-01221
• Device Sequence Number: 10673664
• 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): 12/05/2025

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 Model Number: 01.26.2858MHC
• Device Lot Number: 2114157
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Age: 69 YR
• Patient Sex: Male