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

Model Number	01.26.2852MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent primary left hip surgery with a custom acetabular cup on (b)(6) 2026, under compassionate use.Approximately three weeks later, the patient experienced a dislocation of the liner from the head after a twisting movement.The dislocation was manually reduced without the use of anesthesia.
Additional Manufacturer Narrative
Batch review performed on 21 april 2026 liner: impact dm 01.26.2852mhc double mobility hc liner d 28/dmf lot.2302832: (b)(4) items manufactured and released on 27 september 2023.Expiration date: 06 september 2028.No anomalies found related to the problem.To date, (b)(4) items from the same lot have been sold, with no similar reported events during the review period.Root cause: based on the information available, no definitive root cause can be established, considering that the patient underwent seven hip surgeries and that the risk of further dislocation is relatively high.Furthermore, 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 did not identify any potential manufacturing-related issues.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: DOUBLE MOBILITY HC LINER Ø28/DMF
• 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: 25148978
• Report Number: 3005180920-2026-00412
• Device Sequence Number: 16138565
• Product Code: MEH
• UDI-Device Identifier: 07630030807343
• UDI-Public: 07630030807343
• Combination Product (Y/N): N
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/12/2026

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: 01.26.2852MHC
• Device Lot Number: 2302832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 89 KG