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

Device Problem Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

Investigations are in progress.A complete and final mdr report will be submitted when all investigations are performed.

Event 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: in2bones was informed that a revision surgery was performed due to a loosening of the tibial implant.No other patient nor user consequences were reported.

Event 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: in2bones was informed that a revision surgery was performed due to a loosening of the tibial implant.No other patient nor user consequences were reported.

• Brand Name: QUANTUM
• Type of Device: QUANTUM TOTAL ANKLE PROSTHESIS
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• Manufacturer (Section G): IN2BONES SAS; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• Manufacturer Contact: sabina ahaddad ; 28 chemin du petit bois; batiment 2; ecully, 69130 ; FR 69130
• MDR Report Key: 17797953
• MDR Text Key: 324021960
• Report Number: 3010470577-2023-02061
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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 Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1