MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TIBIAL TRAY, SIZE 2X, RIGHT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10207112

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 08/05/2021

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

A physician reported that a total ankle arthroplasty was performed in a (b)(6)-year-old patient on (b)(6) 2020.On (b)(6) 2021, there was loosening and failure of the implant and it was removed and replaced with a competitor implant on (b)(6) 2021.

Manufacturer Narrative

The cadence tibial tray was returned for evaluation.Dhr review: a review of the lot records identified no indications of problems or issues which could have caused or contributed to the alleged complaint.Failure analysis: visual examination of the part found that one peg of the tibial tray was broken off from the base of the tray.The broken peg was also included in the return shipment.The reported loosening of the implant was most likely caused by the broken condition of the peg.The failure was confirmed.Root cause: evaluation of the returned part verified that the reported loosening of the implant was most likely caused by the broken condition of the peg.A definitive root cause for the failure could not be identified.

Event Description

N/a.

• Brand Name: CADENCE TIBIAL TRAY, SIZE 2X, RIGHT
• Type of Device: CADENCE TOTAL ANKLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12851136
• MDR Text Key: 281073152
• Report Number: 1651501-2021-00051
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 10207112
• Device Lot Number: 190780G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• 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
• Patient Age: 64 YR