MAUDE Adverse Event Report: IN2BONES SAS QUANTUM®; QUANTUM® TOTAL ANKLE PROSTHESIS

Catalog Number	M50 SU149
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch record 2010099 was reviewed and found to be compliant.7 implants were released on 21/oct/2021.They were machined by cf plastiques as per manufacturing drawings and specifications in progress, as per of-84616.The batch was accepted with 2 concessions (dd1911-16 and dd2001-03) regarding modification of the inspection means used by the supplier.All modifications involved were then implemented in the inspection specifications.The quantum range (talar implant, insert, tibial implant and connexion between insert and tibial implant) is not questioned by the event reported in the complaint.The pe insert was not correctly clipped in the tibial implant by the user.The final insert insertion step recommended on the surgical technique manual "st-dig-quantum-en-102021" was not followed by the user.
Event or Problem Description
The quantum® total ankle prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.The quantum® total ankle prosthesis is a fixed-bearing, semi-constraint ankle prothesis with 2 components and composed of: a tibial component composed of a metallic (ta6v) tibial tray implant fixed to a polymer (uhwmpe) insert, a metallic (cocr) talar implant reproducing the talus dome anatomy.When all components are implanted, with the insert rigidly locked to the tibial tray, the polyethylene insert acts as a single bearing along the talar dome, enabling flexion/extension and rotation movement at the replaced ankle joint.Each component of the quantum® total ankle prosthesis exists in different sizes and models.Event description: incident description as per the complaint initiator: "insert s4 was not inserted all the way into tibial implant s5 by the surgeon." additional information discussed during in2bones codir performed on (b)(6) 2022: initial surgery performed on (b)(6) 2022.The x-ray control performed on (b)(6) 2022 shows that the talar implant is correctly placed but the pe insert seems to be incorrectly clipped inside the tibial implant.A revision surgery to secure the insert into the tibial implant is planned by dr (b)(6) on (b)(6)2022.This incident is related to dr (b)(6) patient 15.Additional information received by the surgeon following reintervention: ossifications are starting to appear.This event is reported according to the remediation plan following fda observation 1 from 04-sept-2025.

• Brand Name: QUANTUM®
• Common Device Name: QUANTUM® TOTAL ANKLE PROSTHESIS
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: martin geertsema ; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 23082214
• Report Number: 3010470577-2025-03081
• Device Sequence Number: 4965793
• Product Code: HSN
• UDI-Device Identifier: 03701337602147
• UDI-Public: 3701337602147
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M50 SU149
• Device Lot Number: 2010099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male