MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P SHORT NECK STD STEM SIZE3

Model Number	01.12.253
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month and half after the primary, the patient came in presenting pain as the result of a subsided stem and the cause is unknown.There was no indication of trauma.The surgeon revised the stem (size 3 to 5), the head and liner (same size).The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 march 2026: lot 2508047: (b)(4) items manufactured and released on 07-aug-2025.Expiration date: 2030-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: implant subsidence 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.

• Brand Name: QUADRA P FEMORAL STEMS
• Common Device Name: QUADRA-P SHORT NECK STD STEM SIZE3
• 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: 24924650
• Report Number: 3005180920-2026-00322
• Device Sequence Number: 13086167
• Product Code: LZO
• UDI-Device Identifier: 07630971243446
• UDI-Public: 07630971243446
• 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): 04/20/2026

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: 01.12.253
• Device Lot Number: 2508047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: White