MAUDE Adverse Event Report: ZIMMER INC TM TOTAL ANKLE TALAR COMPONENT; KXC

Catalog Number 00830002400

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Information was received from a foreign consumer who is not required to complete form 3500a.(b)(4).Other device used: catalog #00830004400, tm total ankle tibial base, lot #62615275.Catalog #00830005400, tm total ankle insert component, lot #62861441.This report will be amended when our investigation is complete.

Event Description

It is reported that the patient is experiencing dorsiflex.Patient being monitored.

Manufacturer Narrative

The trabecular metal total ankle was designed with a minimum of 15 degrees of plantarflexion and 15 degrees of dorsiflexion.However as stated in the instructions for use included with the implant, "total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint." as described in the article, "postoperative range of motion trends following total ankle arthroplasty" by ajis, henriquez and myerson in the may 2013 issue of the foot and ankle international journal, total ankle replacement does not significantly increase the range of motion of the ankle, but is rather indicative of the preoperative range of motion the patient exhibited prior to the procedure.No devices or photos were returned therefore a determination on the condition of the devices cannot be made.Review of the device history records did not find any deviations or anomalies.The devices were used for treatment.No other complaints of any type have been reported for the provided lots.The reported devices are an approved and compatible combination.With the provided information an exact cause could not be determined.

• Brand Name: TM TOTAL ANKLE TALAR COMPONENT
• Type of Device: KXC
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5249816
• MDR Text Key: 32105325
• Report Number: 1822565-2015-02460
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

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 Catalogue Number: 00830002400
• Device Lot Number: 62876087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other