MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; OFFSET 4MM PE HC LINER Ø36/E

Model Number	01.32.3644HC4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2025: lot 2210001: (b)(4) items manufactured and released on 15-jun-2022.Expiration date: 2027-05-31.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.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2023.On (b)(6) 2024, the patient came in reporting pain due to a loose stem.The surgeon revised the medacta stem, head and liner with another medacta stem, head and liner, and complaint (b)(4) was filed.Mdr 3005180920-2024-00190 and 3005180920-2024-00190 fu1.On (b)(6) 2025, the patient came in reporting pain due to a loose stem.The surgeon revised the medacta stem and head with a competitor's components and revised the medacta liner with another medacta liner.The surgery was completed successfully.Complaint (b)(4) filled.Mdr 3005180920-2025-00204.Presently, on (b)(6) 2025, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the competitor head and medacta liner and cup.The surgery was completed successfully.The cup was revised just because the surgeon wanted give it different positioning/inclination/version this time.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: OFFSET 4MM PE HC LINER Ø36/E
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22539699
• Report Number: 3005180920-2025-00690
• Device Sequence Number: 7904400
• Product Code: LPH
• UDI-Device Identifier: 07630040731058
• UDI-Public: 07630040731058
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 01.32.3644HC4
• Device Lot Number: 2210001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2022
• 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 Sex: Male