MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø28/DMH

Model Number	01.26.2856MHC
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-02-2025 lot 147167: (b)(4) items manufactured and released on 03-12-2014.Expiration date: 2019-10-31.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.Preliminary investigation: the images show the shell and the liner with the femoral head inside it; there are no visible evident signs that can be related to the event; for these reasons, it is not possible to determine the root cause from the received information.The device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
At about 10 years from primary, the patient came in reporting pain due to a worn liner.The surgeon revised the cup, head and liner.The surgery was completed successfully.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø28/DMH
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21695299
• Report Number: 3005180920-2025-00185
• Device Sequence Number: 21159276
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: 10/31/2019
• Device Model Number: 01.26.2856MHC
• Device Lot Number: 147167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2014
• 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