MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TALAR DOME, SIZE 1, LEFT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10208201

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported the pegs of the cadence talar dome were broken, found during the patient's 16 months postoperative follow up.The pegs appeared intact in the 3 weeks postoperative follow up.The patient is not in pain, therefore, a revision surgery is not planned.

Manufacturer Narrative

A review of the device history record was conducted and did not discover any indication of problems that could have caused or contributed to the complaint.Failure analysis - the part was not returned for investigation, but x-ray images of the talar dome were provided.The x-ray images show that both pegs of the talar dome are broken and detached from the body of the implant at the point where the pegs attach to the body.The failure is confirmed.As the part was not returned for examination, no definitive root cause could be determined.If the part is later returned this complaint may be reopened and an analysis performed.

Event Description

N/a.

• Brand Name: CADENCE TALAR DOME, SIZE 1, LEFT
• Type of Device: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• MDR Report Key: 10319337
• MDR Text Key: 200879748
• Report Number: 1651501-2020-00010
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K151459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 10208201
• Device Lot Number: QJ0702-G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1