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

Model Number	01.26.2850MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain due to a dislocation of the dm liner from the dm converter liner.The cause is unknown.There was no indication of trauma.The surgeon revised the 28 mm biolox delta head l to a cocr ball head 12/14 d 28 mm size xl and revised the double mobility hc liner d 28/dme to a same size liner.The surgery was completed successfully.The patient had an mpact mh with dm converter on (b)(6) 2026 in a revision of competitor devices.
Additional Manufacturer Narrative
Batch review performed on 24 june 2026: ball heads: mectacer 01.29.203 mectacer head biolox delta dia.28 12/14-l (k112115) lot 2513372: (b)(4) items manufactured and released on 28-may-2025.Expiration date: 13-may-2030.No anomalies found related to the problem.To date, 63 items of the same lot have been sold with no similar reported event during the period of review.Liner: mpact 01.26.2850mhc double mobility hc liner d 28/dme (k092265) lot 2521259: 110 items manufactured and released on 06-oct-2025.Expiration date: 15-sep-2030.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.Root cause: based on the information available, no definitive root cause can be established for the reported dislocation of the double mobility liner from the dm converter liner.No trauma was indicated, and the available information does not allow confirmation of a specific clinical, application-related, or device-related cause.The device history record reviews for the involved lots did not indicate any potentially related manufacturing issue, and no similar events were identified for the reviewed sold items of the same lots.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: DOUBLE MOBILITY HC LINER Ø28/DME
• 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: 25663304
• Report Number: 3005180920-2026-00614
• Device Sequence Number: 5596151
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (Y/N): N
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 06/30/2026

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: 01.26.2850MHC
• Device Lot Number: 2521259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2025
• 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: Female