MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS CADENCE TALAR DOME, SIZE 2, RIGHT; CADENCE TOTAL ANKLE SYSTEM

Catalog Number 10208102

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 broken pegs of a talar implant.The implant was placed on (b)(6) 2017, on a (b)(6) year old patient.The surgeon was reviewing x-rays taken in 2019, and detected the broken pegs.The first time he saw the x-rays he did not notice that it was broken.The patient has good mobility, does not have pain and no trauma was reported and actually, there is no action plan.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Dhr - the lot records were reviewed and no problems were identified that could have caused or contributed to the complaint.The part has not yet been returned to integra for investigation, but x-ray images were provided.Evaluation of the x-ray image shows that a peg of the talar dome was broken off from the talar dome at the point where the peg joins the dome.The failure was confirmed.As the part has not yet been returned, a definitive root cause cannot be determined.According to risk management documentation for the cadence total ankle system, there are several identified failure modes which could result in breakage of the talar dome, including inadequate design and incorrect or inadequate surgical technique.If the part is later returned this complaint may be reopened and an analysis performed.

Manufacturer Narrative

Additional information received: the dysfunction was observed 36 months after the implantation.Implant extraction is not planned as patient is asymptomatic.

Event Description

N/a.

• Brand Name: CADENCE TALAR DOME, SIZE 2, 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: 11499462
• MDR Text Key: 263604706
• Report Number: 1651501-2021-00004
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

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: 09/01/2020
• Device Catalogue Number: 10208102
• Device Lot Number: QJ0458-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 03/15/2021; 11/23/2021
• Supplement Dates FDA Received: 04/21/2021; 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• 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: 57 YR