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

Catalog Number	M50 ST240
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medical device description: the quantum® total ankle prosthesis is a fixed-bearing semi-constraint ankle prothesis with 2 components existing in different sizes and models 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: initial surgery date: (b)(6) 2022.Situation: tibial implant migration and postoperative malleolar fracture the patient underwent revision surgery following an x-ray examination showing a periproteal malleolar fracture and varus migration and anterior slope of the quantum tibial implant.The revision surgery took place on monday (b)(6) 2023.The tibial implant and polyethylene insert were explanted, a 2.0mm tibial cut was made and a new tibial implant and insert were re-implanted.The replacement tibial implant was cemented to ensure tibial stability.The malleolar fracture was not synthesized, as it was already partially consolidated.71-year-old patient, very hard bone, difficulty in bone preparation during both operations.Patient returned to weight-bearing immediately after the first surgery, without plaster cast or walking boot.Fracture of medial malleolus compromised stability of tibial implant not held in tibiofibular mortise.The initiator reported that the patient bones quality leads to difficulty in bones preparation during both surgeries.Additionally, too early stress on the ankle without a sufficient period of immobilization after the surgery may lead to fracture of medial malleolus which may have compromised stability of tibial implants.Note: this reportable event is part of a remedition resulting from a 483 letter.
Additional Manufacturer Narrative
Batch record was reviewed and found to be documentary compliant.The review did not identify any incidents related to the manufacture of this implant.The design of the implant is not questionned, and the event is not related to the implant itself.As reported by the initiator, the patient bones quality leads to difficulty in bones preparation during both surgeries.Additionally, too early stress on the ankle without a sufficient period of immobilization after the surgery may lead to fracture of medial malleolus which may have compromised stability of tibial implants.Note: this reportable event is part of a remedition resulting from a 483 letter.

• 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: 23093730
• Report Number: 3010470577-2023-04201
• Device Sequence Number: 18594219
• Product Code: HSN
• UDI-Device Identifier: 03701337601393
• UDI-Public: 3701337601393
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 09/19/2025

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 Catalogue Number: M50 ST240
• Device Lot Number: 1906306
• 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: 03/29/2023
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male