MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA P FEMORAL STEMS; QUADRA-P STD STEM SIZE1

Model Number	01.12.121
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 11 months after the primary, the patient came in presenting pain due to a loose stem and the cause is unknown.There are no indications of trauma.The surgeon revised the stem and head to competitor implants, and revised the liner to same size medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 february 2026.Lot 2305943: (b)(4) items manufactured and released on 26-july-2023.Expiration date: 2028-07-04.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.Clinical analysis: 2 years after primary cementless tha, the stem becomes painful and requires exchanging.The proximal part of the femur appears to be rarefied, and the stem seems to be undersized in this image, but of course the postoperative xray set would be needed to assess proper sizing.The surgeon is very experienced and familiar with this type of stems, so it is most likelly that the primary stability at index surgery was satisfactory.We cannot determine the causes for bone rarefaction and subsequent loosening, but we cannot think of a plausible cause directly related to implant defect or malfunction.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.From the post-operative images, the proximal part of the femur appears to be rarefied, and the stem seems to be undersized.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 STD STEM SIZE1
• 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: 24558210
• Report Number: 3005180920-2026-00152
• Device Sequence Number: 9331205
• Product Code: LZO
• UDI-Device Identifier: 07630040720427
• UDI-Public: 07630040720427
• Combination Product (Y/N): N
• PMA/510(K) Number: K181254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/10/2026

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: 01.12.121
• Device Lot Number: 2305943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White