MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; FLAT PE HC LINER Ø36/E

Model Number	01.32.3644HCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed after 1 year and 1 month from the primary procedure due to instability.The patient had previously experienced a dislocation, which was treated with a closed reduction.The surgeon revised the liner.The surgery was successfully completed.
Additional Manufacturer Narrative
Batch review performed on 23 dec 2025.Lot 2405627: (b)(4) items manufactured and released on 21 march 2024.Expiration date: 10 march 2029.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: the surgeon revised liner height, which is a common practice to restore the joint stability.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: FLAT PE HC LINER Ø36/E
• 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: 23920162
• Report Number: 3005180920-2025-01336
• Device Sequence Number: 18465464
• Product Code: LPH
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• Combination Product (Y/N): N
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/30/2025

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: 01.32.3644HCT
• Device Lot Number: 2405627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2024
• 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
• Patient Race: White