MAUDE Adverse Event Report: IN2BONES SAS QUANTUM; QUANTUM® TIBIAL IMPLANT

Device Problems Failure to Osseointegrate (1863); Migration (4003)

Patient Problems Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544); Implant Pain (4561)

Event Date 12/13/2022

Event Type  Injury  

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: one surgeon based in belgium reported 4 cases of lucency (border on xrays) around the tibial component associated to pain for 4 of his patients (2 of them might need a revision surgery later):.Patient number 12 = lucency with pain reported 1 year post-operative;.Patient number 14 = lucency with pain reported 6 months post-operative;.Patient number 16 = lucency with pain reported 6 months post-operative;.Patient number 17 = lucency with pain reported 4 months post-operative.Additional information are to be collected and investigations are in progress.

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 : one surgeon based in belgium reported 4 cases of lucency (border on xrays) around the tibial component associated to pain for 4 of his patients (2 of them might need a revision surgery later): patient number: 12 = lucency with pain reported 1 year post-operative; patient number: 14 = lucency with pain reported 6 months post-operative; patient number: 16 = lucency with pain reported 6 months post-operative; patient number: 17 = lucency with pain reported 4 months post-operative.Additional information communicated by the surgeon: for patient 12 = information communicated during meeting on (b)(6) 2023: the significant lucency reported for patient 12 might have been induced by a user error during the initial surgery (10° of valgus induced by error when using the psi).For patient 14 = information communicated during meeting on (b)(6) 2023: young patient, very active, that had an active reeducation.The patient had an infiltration for pain management and will be closely monitored.A small artifact seems to be present around the tibial implant.Addition information received by in2bones on march 2nd, 2023 (e-mail): the patient has been reviewed by the surgeon (9 months post-operative), it seems that a small fragment of coating has been detached from the tibial implant.For patient 16 = information communicated during meeting on (b)(6) 2023: this patient also has an important tibial periosteal reaction, and the tibial implant lucency is associated to a tilt of the tibial implant.This patient is closely monitored and might need a revision surgery.Additional information communicated during meeting on (b)(6) 2023 : a revision surgery is being planned for this patient.For patient 17 = information communicated during meeting on (b)(6) 2023: for this patient, the lucency might be related to an insufficient impaction of the tibial implant intra-operatively.This patient has osteoporotic bones.A revision surgery might be required for this patient at a later date.Additional information communicated during meeting on (b)(6) 2023 : a revision surgery is being planned for this patient.

• Brand Name: QUANTUM
• Type of Device: QUANTUM® TIBIAL IMPLANT
• 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: 17798265
• MDR Text Key: 324029628
• Report Number: 3010470577-2022-12071
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other