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

Model Number	01.32.3644HCAT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, the patient had primary hip surgery.On (b)(6) 2025, the patient came in reporting pain due to a loose stem and the cause is unknown.The surgeon revised the medacta stem and head with competiitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully (b)(4).On (b)(6) 2025, the patient came in due to pain and the cause is unknown.The surgeon revised the liner to provide more offset.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 november 2025.Liner: mpact 01.32.3644hcat hooded pe hc liner d 36/e lot 2239590: (b)(4) items manufactured and released on 17-nov-2022.Expiration date: 02-nov-2027.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, 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.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: HOODED 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: 23669512
• Report Number: 3005180920-2025-01203
• Device Sequence Number: 9881937
• Product Code: LPH
• UDI-Device Identifier: 07630030812101
• UDI-Public: 07630030812101
• Combination Product (Y/N): N
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/28/2025

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: 01.32.3644HCAT
• Device Lot Number: 2239590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: 78 YR
• Patient Sex: Female