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

Catalog Number M50 ST221

Device Problem Failure to Osseointegrate (1863)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  Injury  

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 : an irish surgeon is planning a prosthesis revision surgery for one of his patients.At the 9 months follow-up, the control ct scan shows a tilted tibial component and a dislocated insert.The patient is asymptomatic.The patient previously had an arthrodesis of the talus navicular and first cuneiform bone.The revision has not been performed yet (no planned date communicated), but the surgeon plans to revise the tibial component with a bone recut to correct the slope and cementing of the new tibial implant.The insert will also be changed but no revision of the talar component.Additonal information are to be collected and investigations are in progress.

Manufacturer Narrative

In2bones will continue to monitor and record such events, if any.If additional information are received on this incident, an update of this vigilance report will be 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 : an irish surgeon is planning a prosthesis revision surgery for one of his patients.At the 9 months follow-up, the control ct scan shows a tilted tibial component and a dislocated insert.The patient is asymptomatic.The patient previously had an arthrodesis of the talus navicular and first cuneiform bone.The revision has not been performed yet (no planned date communicated), but the surgeon plans to revise the tibial component with a bone recut to correct the slope and cementing of the new tibial implant.The insert will also be changed but no revision of the talar component.

• Brand Name: QUANTUM®
• Type of Device: QUANTUM® TOTAL ANKLE PROSTHESIS
• Manufacturer (Section D): IN2BONES SAS; 28 chemin du petit bois; bâttiment 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: 19048765
• MDR Text Key: 339431231
• Report Number: 3010470577-2024-03041
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K191380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Catalogue Number: M50 ST221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female