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

Model Number	01.26.2848MHC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Liner: versafitcup dm 01.26.2848mhc double mobility hc liner d 28/dmd (k092265) lot.Unknown ball heads: mectacer 01.29.202 mectacer head biolox delta dia.28 12/14-m (k112115) lot.Unknown.Since we do not have the product lot numbers, devices, xrays and lack information regarding the primary surgery, we are unable to perform further analyses.No issues related to the reference have been identified.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.
Event or Problem Description
The patient had revision surgery of medacta product but the primary ticket for the patient cannot be located.The patient came in due to instability and the cause is unknown.The surgeon, according to the complaint, revised a d 48 dm liner and 28mm m head to the same size medacta liner and head with a sleeve to improve patient stability.The surgery was completed successfully.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: DOUBLE MOBILITY HC LINER Ø28/DMD
• 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: 23837347
• Report Number: 3005180920-2025-01273
• Device Sequence Number: 20091653
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• Combination Product (Y/N): N
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/18/2025

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: 01.26.2848MHC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: White