MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P COLLARED STD. SIZE4

Model Number	01.12.164
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 march 2026.Stem: quadra-p collared 01.12.164 quadra-p collared std.Size 4 (k192827) lot 2510361: (b)(4) items manufactured and released 28-aug-2025.Expiration date: 05-aug-2030.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: a few days after primary cementless tha, the patient complains of a fracture at the lesser trochanter level, with no reported trauma.It is conceivable that the bone was damaged during femoral preparation; this is a possible adverse event connected with tha, described in the instructions for use.No real radiograph was supplied; from the intraoperative fluoroscopic image, a rather peculiar femoral shape can be imagined, and this may have contributed to making the femoral preparation rather difficult and riskier.It seems that the surgeon, a highly experienced professional in total joint replacement, performed a rather low resection: there must be a reason for this choice, but it&size39; s difficult to tell because of the lack of images provided.No reason to suspect that the adverse event was caused by a defective or malfunctioning device.Root cause: bone fracture is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 3 weeks from the primary, the patient came in presenting hip pain due to a fracture of the lesser trochanter and calcar bone loss.There were no indications of trauma.The surgeon revised the quadra p size4 stem to a quadra r size 4 stem and the biolox 40mm head m to a biolox 40mm head s.The surgery was completed successfully.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P COLLARED STD. SIZE4
• 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: 24681022
• Report Number: 3005180920-2026-00229
• Device Sequence Number: 15895415
• Product Code: LZO
• UDI-Device Identifier: 07630040731881
• UDI-Public: 07630040731881
• Combination Product (Y/N): N
• PMA/510(K) Number: K192827
• 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): 03/24/2026

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: 01.12.164
• Device Lot Number: 2510361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2025
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Race: White