MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA "H" SHORT NECK, CEM.LESS, LAT., HAP S.1

Model Number	01.12.31SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation 8 years after cementless tha, the stem gets loose and requires revision.The quality of the one image supplied is such that little conclusion can be drawn.There seem to be no evident signs of osteolysis or other traces of a worn implant.This is probably a case of late idiopathic aseptic loosening and we see no reason to suspect a faulty device.Batch review performed on 08 apr 2026: lot 114752: (b)(4) items manufactured and released on 12-jan-2012.Expiration date: 2016-nov-30.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.In this case, the absence of osteolysis or implant wear, together with the lack of evidence linking the event to device design or manufacturing issues and no similar prior cases, suggests a late idiopathic aseptic loosening not attributable to device malfunction.
Event or Problem Description
Revision surgery due to stem loosening about 8 years and 3 months after primary surgery.There was no indication of trauma.The surgeon made no note of bone quality.The surgeon revised the medacta stem and head to a competitor stem and head, and revised the medacta liner to a same size liner.The surgery was completed successfully.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA "H" SHORT NECK, CEM.LESS, LAT., HAP S.1
• 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: 25012258
• Report Number: 3005180920-2026-00350
• Device Sequence Number: 10399597
• Product Code: JDI
• UDI-Device Identifier: 07630030802713
• UDI-Public: 07630030802713
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/28/2026

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 Expiration Date: 09/20/2021
• Device Model Number: 01.12.31SN
• Device Lot Number: 114752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2012
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White