MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 4X, RIGHT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10207114

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Dhr: there were no indications of problems that could have caused or contributed to the complaint.Failure could not be confirmed, the cadence tibial implant remains implanted.If the part is later returned to integra this investigation may be reopened and updated.As the part has not yet been returned, a definitive root cause cannot be determined.According to risk assessment documentation for the cadence total ankle system, potential causes for osteolysis with the tibial tray include inadequate design and incorrect or inadequate surgical technique.

Event Description

1 of 2 reports.Other mfg report number: 1651501-2020-00023.Case from a study: a right cadence tibial implant (size 4x) was placed on (b)(6) 2019 and on a follow up visit on (b)(6) 2020 the surgeon noted on the x-rays: "osteolysis on both tibia and talus (bone cyst around the posterior side of the tibial implant / osteolysis under the talus implant".No action or treatment plan for the moment.Surgeon advised patient to come back in 3 months for follow up.

Manufacturer Narrative

Additional information received on june 4, 2021: revision surgery was scheduled on (b)(6) 2021 with talus and poly exchange and potentially a tibia exchange.Additional information received on june 11, 2021: revision surgery cancelled, the patient had functional improvement since 6 weeks before the appointment on (b)(6) 2021 (unlimited walking distance, golf etc.).

Manufacturer Narrative

Additional information received: the site indicated that the planned revision surgery was cancelled as the patient was pain free and had adequate mobility.

• Brand Name: CADENCE TIBIAL TRAY, SIZE 4X, RIGHT
• Type of Device: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 10987868
• MDR Text Key: 220892454
• Report Number: 1651501-2020-00022
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K151459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 10207114
• Device Lot Number: 180579G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1