MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM QUADRA LATERIZED HAP 12/14 S3

Model Number	01.12.033
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: 13 years after primary cementless tha, the stem is loose and needs replacement.The cup is stable, but the surgeon decides to replace it nonetheless, as a precautionary measure.There are visible signs of osteolysis in the proximal femur, but the surgical report does not mention any significant findings.The original insert was ceramic, so osteolysis cannot be due to pe wear debris.There is no radiographic history to allow us to evaluate the sizing and positioning of the primary stem; however, the long service time vouches for a good implantation and result.The causes for osteolysis and subsequent mobilization cannot be determined with the information at hand.Batch review performed on 31 march 2026: lot 122033: (b)(4) items manufactured and released on 31-jul-2012.Expiration date: 2017-jun-30.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Root cause: aseptic loosening is possible literature described adverse event after primary hip 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 and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
Primary surgery performed on (b)(6) 2012.On (b)(6) 2026 (13 years and 3 months post primary) revision surgery on the right-side hip performed for loosening of the stem.Head and stem revised.Successfully.No loosening of the acetabular shell.No infection.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM QUADRA LATERIZED HAP 12/14 S3
• 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: 24964784
• Report Number: 3005180920-2026-00329
• Device Sequence Number: 10363676
• Product Code: JDI
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 04/23/2026

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: 06/30/2017
• Device Model Number: 01.12.033
• Device Lot Number: 122033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 89 KG