MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM STANDARD HAP 12/14 S.3

Model Number	01.12.023
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 two surgeons undertook their first amis list with a proctoring consultant present to support.An mpact cup and quadra h stem were inserted through the anterior approach using the amis leg positioner.On table x-rays looked fine, with the final image being taken with the definitive implants insitu immediately prior to closure.No signs of fracture are visible on any xray taken during the case.Later that evening the patient was taken for a post op x-ray which identified a vancouver b1 periprosthetic fracture.A ct scan later showed no fracture in the calcar.Re-operation to fix the fracture with an the following day, stem not revised.
Additional Manufacturer Narrative
Batch review performed on 02 february 2026: lot 2435498: (b)(4) items manufactured and released on 05-may-2025.Expiration date: 2030-apr-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.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 H FEMORAL STEMS
• Common Device Name: QUADRA STEM STANDARD HAP 12/14 S.3
• 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: 24376305
• Report Number: 3005180920-2026-00105
• Device Sequence Number: 14845899
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 02/18/2026

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: 01.12.023
• Device Lot Number: 2435498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2025
• 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 Ethnicity: Non Hispanic
• Patient Race: White