MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P SHORT NECK STD STEM SIZE 2

Model Number	01.12.252
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At about 2 months from primary, the patient came in reporting pain.Origin of the pain was identified in a fracture of the femur caused by stem subsidence.Currently, the surgeon does not plan to perform a revision surgery as stem seems stable and fracture should heal on its own.Walker and conservative weight bearing prescribed.
Additional Manufacturer Narrative
Batch review performed on 22-dec-2025.Lot: 2409915: (b)(4) items manufactured and released on 29-jul-2024 expiration date: 2029-07-03.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.Clinical evaluation performed by clinical affairs department.A few weeks after primary cementless tha the stem subsides slightly and causes a small crack in the femur.The surgeon decided to take no surgical action and only prescribed controlled weight bearing.The poor quality of the images supplied does not allow to express an opinion on possible causes of subsidence, such as stem undersizing.We see no reason to suspect a faulty or defective implant at the origin of this adverse event.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.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P SHORT NECK STD STEM SIZE 2
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24004374
• Report Number: 3005180920-2026-00014
• Device Sequence Number: 10239516
• Product Code: LZO
• UDI-Device Identifier: 07630971243439
• UDI-Public: 07630971243439
• Combination Product (Y/N): N
• PMA/510(K) Number: K192827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 01.12.252
• Device Lot Number: 2409915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2024
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White