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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 feb 2026 liner: mpact dm 01.26.2850mhc double mobility hc liner d 28/dme (k092265) lot 2312619: (b)(4) items manufactured and released on 21-jun-2023.Expiration date: 2028-jun-04.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.Ball heads: mectacer 01.29.202 mectacer head biolox delta dia.28 12/14-m (k112115) lot 2101449: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-06.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.Clinical evaluation performed by clinical affairs director.2 years after primary cementless tha, the joint presents instability and the surgeon revised the head to a longer one, exchanging the pe liner as well, as customary.No reason to suspect a performance deterioration of the devices.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.
Event or Problem Description
At 1 year 11 months from primary, the patient came in presenting instability and the cause is unknown.The surgeon revised the d 28 double mobility liner to a liner of the same size and revised the 28mm biolox head to a head of the same size with a biolox option sleeve l.The surgery was completed successfully.

• 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: 24588556
• Report Number: 3005180920-2026-00209
• Device Sequence Number: 21203632
• 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: 2024
• 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): 03/13/2026

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: 2312619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White