MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL; MPACT 3D METAL SHELL TWO HOLE Ø52MM

Model Number	01.38.052DH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain due to a mispositioned cup and the cause is unknown.The surgeon revised the medacta cup and liner to competitor components and the medacta head to a medacta head.The surgery was completed successfully.The cause of the malpositioned cup is unknown.The head was revised to add more stability.
Additional Manufacturer Narrative
Batch review performed on 17 june 2025: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-11-15.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.

• Brand Name: MPACT 3D METAL
• Common Device Name: MPACT 3D METAL SHELL TWO HOLE Ø52MM
• 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: 22343744
• Report Number: 3005180920-2025-00619
• Device Sequence Number: 4799488
• Product Code: LPH
• UDI-Device Identifier: 07630030812590
• UDI-Public: 07630030812590
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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: 01.38.052DH
• Device Lot Number: 2111315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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 Weight: 65 KG
• Patient Race: White