MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TALAR DOME, SIZE 3, RIGHT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10208103

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

Patient Problem Implant Pain (4561)

Event Date 03/10/2021

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

2 of 3 reports.Same patient, same procedure, different products.Other mfg report numbers: 1651501-2021-00021, and 1651501-2021-00023.Report from a clinical study: ankle stiffness; per data review conducted on 26 january 2021, ¿ankle stiffness¿ was reported on (b)(6) 2021, in the (b)(6) clinical study.The description stated ¿painless ankle stiffness for 6 weeks limited dorsiflexion inducing asymmetrical stairs descent¿.This event was determined to be not serious, mild in severity grade, possibly related to device and possibly related to the procedure.No treatment was required and this event remains ongoing.Additional information received on june 4, 2021: subject sustained antero-medial ankle pain and documented impingement on pet scan from (b)(6) 2021.Ae frequency is reported as intermittent and of moderate severity.The event was classified not-serious and unanticipated by the study investigator.The event was reported as not related to the device but possibly related to the procedure.Subject underwent antero-medial release on (b)(6) 2021.Operated ankle: right.Primary diagnosis: primary arthritis.Previous surgeries: none.Implant date: (b)(6) 2019.

Manufacturer Narrative

The talar dome 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.Additional information received: device was not removed.

Event Description

N/a.

• Brand Name: CADENCE TALAR DOME, SIZE 3, 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: 11971590
• MDR Text Key: 265678668
• Report Number: 1651501-2021-00022
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

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: 09/01/2020
• Device Catalogue Number: 10208103
• Device Lot Number: QJ0459-G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR