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

Catalog Number	M50 SU155; M50 SC145; M50 ST16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
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: as reported by in2bones usa (email dated on october 12th, 2022): « a complaint was received for quantum total ankle system.Sales rep billy ortiz reported that dr.Scott carrington (gundersen health system) removed quantum implants postoperatively due to a patient infection.According to the surgeon, the infection was not caused by or related to the implant.The date of surgery was (b)(6) 2022.Aware date is 10-11-2022.The parts have not been returned to in2bones, usa.Product information: part number.Lot number.Description.M50 su155 1906370 quantum fixed insert implant size 5 right 5mm.M50 sc145 2002121 quantum talar implant flat cut right size 5.M50 st160 2106170 quantum tibial implant stand right size 6.Additional information received on october 12th, 2022 : the prosthesis was completely removed and replaced by an antibiotic spacer ciment block.This event is reported according the remediation plan following fda observation 1 from 04-sept-2025.
Additional Manufacturer Narrative
Batch record 1906370 was reviewed and found to be compliant: (b)(4) products were manufactured as per (b)(4) and released on january 06th, 2021.Batch record 2002121 was reviewed and found to be compliant: (b)(4) products were manufactured as per (b)(4) and released on january 05th, 2021.Batch record 2106170 was reviewed and found to be compliant: (b)(4) products were manufactured as per (b)(4) and released on november 08th, 2021.As per reported by the initiator, the surgeon believed that the incident was not caused nor related to the implant.Infection, not related to the implanted device, is a known adverse event following a foot surgery.This type of adverse event is documented in the quantum ifu and technical documentation.This incident is the first case of infection reported after a quantum surgery.

• 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: 23083115
• Report Number: 3010470577-2025-10121
• Device Sequence Number: 4748609
• Product Code: HSN
• UDI-Device Identifier: 03701337602260
• UDI-Public: 3701337602260
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: M50 SU155; M50 SC145; M50 ST16
• Device Lot Number: 1906370; 2002121; 2106170
• 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: 10/11/2022
• Initial Report FDA Received Date: 09/18/2025
• 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: Other
• Patient Sex: Unknown