MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P SHORT NECK STD STEM SIZE 1

Model Number	01.12.251
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: a few days after the implantation of a total hip arthroplasty, the patient presented with a periprosthetic fracture requiring revision surgery.No trauma was reported; the patient only complained of pain.The available x-rays clearly show a proximal periprosthetic fracture involving the lesser trochanter.Determining the exact root cause is challenging with the current information.However, in the immediate post-operative period, the bone may be weakened due to normal femoral preparation.Additionally, the bone quality of this 83-year-old patient is reported to be poor.In this condition, even a sudden/inadvertent movement may have led to the early fracture.Based on the available information, there is no indication of a device-related issue.Batch review performed on 03-mar-2025: lot 1910214: (b)(4) items manufactured and released on 23-apr-2020.Expiration date: 14-apr-2025.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.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.
Event or Problem Description
At about 2 weeks after primary, the patient came in reporting pain due to a periprosthetic bone fracture.The surgeon revised the stem, head, and liner.The surgery was completed successfully.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P SHORT NECK STD STEM SIZE 1
• 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: 21695440
• Report Number: 3005180920-2025-00202
• Device Sequence Number: 18336462
• Product Code: LZO
• UDI-Device Identifier: 07630971243422
• UDI-Public: 07630971243422
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2025
• Device Model Number: 01.12.251
• Device Lot Number: 1910214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female