MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; MPACT ACETABULAR SHELL Ø50 TWO-HOLES

Model Number	01.32.050DH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 march 2025 lot 2420477: (b)(4) items manufactured and released on 24-oct-2024.Expiration date: 2029-10-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Based on the information available no definitive root cause can be established, while the investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
Revision surgery was performed few days after primary due to malpositioned cup.From the x-rays, the surgeon deemed acetabular position to be sub optimal (vertical position with an increased inclination angle) and chose to change it.The bone was prepared with a 51 mm acetabular reamer and a 52mm cup implanted a 52mm cup in a acceptable position.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
• 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: 21695439
• Report Number: 3005180920-2025-00233
• Device Sequence Number: 18336461
• Product Code: LZO
• UDI-Device Identifier: 07630030810220
• UDI-Public: 07630030810220
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

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: 01.32.050DH
• Device Lot Number: 2420477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male