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

Catalog Number 10207103

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that upon impaction of tibial tray, the posterior aspect of the tibia fractured at location of posterior fin on tibial implant, in addition the medical malleolus was fractured.The event lead to 45 minutes surgical delay.Additional information was requested and the following was received: procedure being performed was a total ankle replacement.The event led to two fractures: medial malleolus during bone removal and posterior fracture during tibial impaction.The medial malleolus was repaired with a plate and no treatment required for posterior fracture.The product will remain implanted unless a revision surgery is needed.

Manufacturer Narrative

Integra has completed their internal investigation on november 10, 2016.The investigation included: methods: review of device history records.Review of complaints history.Results: dhr review; no lot number was provided therefore the manufacturing record could not be determined.Complaints history; a review of the complaint records for the same product (or similar products within the product family) for the alleged hazardous situation/failure mode received, determined three complaints of fractured tibial trays have been received during the lifetime of the product as specified in the risk management plan (rmp), typically 5 years or within the stated timeframe the complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of the review.Complaint rate = (b)(4).Conclusion: a root cause could not be determined due to the absence of the devices to evaluate.Based on the description provided, potential causes for the breakage could be factors such as stress placed upon the medial side of the ankle from the syndesmosis (connective tissues) and performing procedures with hard bone.In addition, if the tibial trays seating is misaligned, the engagement of the posterior fin could potentially fracture the posterior aspect of the tibia during impacting.In this particular case, the surgeon was not concerned and believes that it will heal and that the anterior cortex is covered and well affixed in the hard bone.

• Brand Name: CADENCE TIBIAL TRAY, 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 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6061954
• MDR Text Key: 58600164
• Report Number: 1651501-2016-00039
• 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
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10207103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 60 YR