MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 1X, RIGHT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10207111

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

1 of 3 reports.Same patient, same procedure, different parts.Other mfg report numbers: 1651501-2021-00019 and 1651501-2021-00020.Report from a clinical study: revision surgery performed of polyethylene insert due to pain without evident reason.Subject sustained chronic ankle pain after the surgery.The event was reported to be continuous and of moderate severity.The investigator reported no relation to the study device however a possible relationship to the procedure (primary ankle arthroplasty).

Manufacturer Narrative

Complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: CADENCE TIBIAL TRAY, SIZE 1X, RIGHT
• Type of Device: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 11971568
• MDR Text Key: 255635686
• Report Number: 1651501-2021-00018
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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 Expiration Date: 03/01/2021
• Device Catalogue Number: 10207111
• Device Lot Number: QJ0707-6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1