MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM STANDARD HAP 12/14 S.2

Model Number	01.12.022
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: shortly after primary cemntless tha, the patient feels pain, an arthroscopic psoas release is attempted with no success and finally the stem is revised.The report speaks of a possibly potted stem.From the radiographs supplied, the stem appears to be clearly undersized.We cannot tell what conditions drove an expert surgeon to select a stem so small compared to the size of the femur, so there may have been unspecified factors that contributed to the choice and most probably there was a deceptive feeling of stability at index surgery, but judging from what we can see in the documentation supplied, this stem was undersized.Investigation performed by r&d project manager: from the information reported and the images attached to the complaint it is visible the explanted stem is covered with patient blood.No ha residuals are visible on the stem body.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem failure.Batch review performed on 07 apr 2026: lot 2314776: (b)(4) items manufactured and released on 29-nov-2023.Expiration date: 2028-nov-13.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause:aseptic loosening 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.From the provided radiographs, the stem appears undersized relative to the femur.While unknown factors may have influenced the surgeon¿s choice and initial stability, the available documentation supports this assessment.
Event or Problem Description
Revision surgery due to stem loosening (possible potting of the stem) after about 1 year and 7 months from primary surgery.One month after the primary surgery, the patient underwent an arthroscopic tendon release to relieve pain, but the procedure did not produce the desired results.Revision surgery was then planned and the stem was removed, keeping the cup and liner in the patient.A competitor stem and head was then implanted.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM STANDARD HAP 12/14 S.2
• 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: 25039771
• Report Number: 3005180920-2026-00354
• Device Sequence Number: 21435247
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• 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): 04/30/2026

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: 01.12.022
• Device Lot Number: 2314776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White