MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL ACETABULAR SYSTEM; CUP: MPACT 3D METAL ACETABULAR SHELL Ø52 MULTI-HOLE THIN

Model Number	01.38.352MH
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 1 month after primary, the patient came in reporting pain due to aseptic loosening of the cup and the cause is unknown.The surgeon revised the cup, head, screws and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14-mar-2025.(b)(4) items manufactured and released on 27-sep-2023.Expiration date: 09-sep-2028.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 ACETABULAR SYSTEM
• Common Device Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø52 MULTI-HOLE THIN
• 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: 21760520
• Report Number: 3005180920-2025-00254
• Device Sequence Number: 18334604
• Product Code: LZO
• UDI-Device Identifier: 07630971212589
• UDI-Public: 07630971212589
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K202568
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 01.38.352MH
• Device Lot Number: 2309083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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: 57 YR
• Patient Sex: Female