MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE IMPLANT-UNSPECIFIED; CADENCE TOTAL ANKLE SYSTEM|

Catalog Number XXX-CADENCE IMPLANT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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.According to risk management documentation for the cadence total ankle system, there are several identified failure modes which could result in implant impingement on hard/soft tissue, including fixation of the talar dome violates the subtalar joint; medial and/or lateral malleolus is damaged during bone resection; and incorrect talar trial size selected due to missing or incorrect laser markings.Per the risk management documentation, potential causes for tissue impingement include damage to tissue during bone preparation or insertion and implantation of incorrect sizes for the patient's anatomy.

Event Description

A facility reported a case from a study with cadence total ankle system: left ankle impingement and left medial malleolar stress reaction."the subject came into the clinic (b)(6) 2019 and was diagnosed with l.Ankle impingement.Subject later had a ct scan taken at an outside hospital and was diagnosed with l.Malleolar stress reaction.He elected to undergo surgical intervention after conservative methods of pt failed to relieve him of pain." surgical treatment was performed: "l.Ankle open debridement with partial excision of the medial malleolus and talar neck (osteophyte excision) with l.Ankle internal fixation of medial malleolus.".

• Brand Name: CADENCE IMPLANT-UNSPECIFIED
• 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 ; 1000 campus drive; princeton, NJ 08536 ; 6099362319
• MDR Report Key: 10945991
• MDR Text Key: 219516821
• Report Number: 1651501-2020-00020
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CADENCE IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR