MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA "H" SHORT NECK, CEM.LESS, STD, HAP S.0

Model Number	01.12.20SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 march 2026.Lot 103959: (b)(4) items manufactured and released on 02-feb-2011.Expiration date: 31-dec-2015.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event.Clinical evaluation.About 9 years after primary cementless tha, the stem gets proximally loose and needs replacement, with no trauma and no infection.The stem appears to be perfectly positioned, and admirably small: it is remarkable that a good fit had been obtained, confirming the very good surgical technique.However, after 9 years, the proximal part of the stem lost good bone contact and became painful.This is probably a typical case of idiopathic aseptic loosening, described in the literature, and we see no reason that it can have been generated by a defective or malfunctioning device.R&d project manager analysis looking at the images attached to the complaint and the informations reported, the explanted stem and ceramic femoral head are visible.On the stem body some white spots are visible, it is not possible to identify if they are ha or bone residuals.Additionally, some significant scratches are visible on the stem proximal part and neck regions, which are probably due to revision surgery.Based on the information available, it is not possible to define a root cause of the current complaint.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
Revision surgery performed about 8 years and 10 months after the primary surgery due to stem aseptic loosening.No infection identified and no trauma reported.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA "H" SHORT NECK, CEM.LESS, STD, HAP S.0
• 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: 24826105
• Report Number: 3005180920-2026-00290
• Device Sequence Number: 13051116
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• 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): 04/09/2026

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: 07/03/2021
• Device Model Number: 01.12.20SN
• Device Lot Number: 103959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2011
• 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 Sex: Female