MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA H CEMENTLESS STEM STANDARD SIZE 3

Model Number	01.12.023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-08-2025: lot 2009049: (b)(4) items manufactured and released on 02-12-2020 expiration date: 2025-11-24.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affairs department: a revision surgery was performed approximately four years after the primary tha due to stem loosening.The available radiographic image clearly demonstrates signs of loosening, with radiolucent lines visible around the entire stem.Conclusion: aseptic loosening is a well-documented complication in the literature, frequently associated with multifactorial or unclear etiology.In this case as well, the precise cause of failure cannot be definitively determined based on the information available.However, we do not have elements to suspect a defective or malfunctioning device.
Event or Problem Description
At about 3 years and 11 months from primary the patient underwent revision due to a loose stem.Surgeon revised the stem to a x-acta stem and surgery was completed successfully.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA H CEMENTLESS STEM STANDARD SIZE 3
• 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: 23081974
• Report Number: 3005180920-2025-00854
• Device Sequence Number: 14613702
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/18/2025

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 Expiration Date: 11/24/2025
• Device Model Number: 01.12.023
• Device Lot Number: 2009049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2020
• 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: Unknown