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

Catalog Number	M50 ST140 & M50 SU135
Medical Device Problem Codes	Component Missing (2306); Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
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 : a french surgeon reported difficulties during a quantum surgery: - the surgeon wanted to cement the prosthesis to ensure an optimal fixation, but it seems that the surgeon used too much cement and had difficulties to impact the tibial component selected (size 4).The decision was taken to remove this tibial implant before cement fixation and replace it by a new implant; - a single tibial implant size 4 was available in the o.R, and the surgeon had to use a smaller sized implant than desired (size 3 xl); - the new tibial implant was also cemented; - the pe insert selected (5mm) dovetail was damaged upon insertion.A single implant of this size was available in the o.R and the surgeon had to use a bigger insert (6mm) in replacement.- with all the difficulties reported, the surgery lasted significantly longer than expected.Additonal information are to be collected and investigations are in progress.

• Brand Name: QUANTUM®
• Common Device Name: QUANTUM® TOTAL ANKLE PROSTHESIS
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bätiment 2; ecully, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: sabina ahaddad ; 28 chemin du petit bois; bâtiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 20566388
• Report Number: 3010470577-2024-10021
• Device Sequence Number: 7873510
• Product Code: HSN
• UDI-Device Identifier: 03701337601331
• UDI-Public: 03701337601331
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/30/2024

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 ST140 & M50 SU135
• Device Lot Number: 2112099 & 2210229
• 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: 09/30/2024
• Initial Report FDA Received Date: 10/30/2024
• 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
• Patient Sex: Unknown