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

Model Number M50 ST250

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

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

Event Date 09/03/2022

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 : initial information reported by the surgeon on (b)(6) 2022: the patient was reviewed at his/her 4 months postoperative follow-up.A tilt of the tibial component of the quantum prosthesis was identified in regards to the immediate postoperative results, creating a varus angle (displacement of the tibial component placement between the immediate results and the 4 months results).However, and as reported by the initiator, the patient functional results and pain levels were deemed acceptable.Additional information reported by the surgeon on december 12th, 2022: the patient was reviewed 3 times between (b)(6) and (b)(6) and has an aggravation of his/her pain level despite an infiltration.

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 : - initial information reported by the surgeon on (b)(6) 2022: the patient was reviewed at his/her 4 months postoperative follow-up.A tilt of the tibial component of the quantum prosthesis was identified in regards to the immediate postoperative results, creating a varus angle (displacement of the tibial component placement between the immediate results and the 4 months results).However, and as reported by the initiator, the patient functional results and pain levels were deemed acceptable.- additional information reported by the surgeon on (b)(6) 2022: the patient was reviewed 3 times between (b)(6) and has an aggravation of his/her pain level despite an infiltration.- additional information reported by the surgeon: this patient was revised on (b)(6) 2023: the quantum prosthesis was removed and replaced by a competitor prosthesis with cement.

• 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: 17797813
• MDR Text Key: 324016892
• Report Number: 3010470577-2022-09041
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Device Model Number: M50 ST250
• Device Lot Number: 1906284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2022
• 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): Life Threatening; Disability