MAUDE Adverse Event Report: ZIMMER INC ZIMMER TM TIBIAL ANKLE BASE PLATE; HSN

Catalog Number 00830004300

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.(b)(4).Other devices used: catalog #00830005300, tm total ankle talus, lot #62952659; catalog #00830005300, tm total ankle talus, lot #62861378.This report will be amended when our investigation is complete.

Event Description

It is reported the patient is experiencing a partial tear of peroneal tendons.

Manufacturer Narrative

This report is being amended to reflect changes in sections.No devices or photos were provided; as such a determination on their condition could not be made.Review of the device history records for the provided lots did not find any deviations or anomalies.The devices were used for treatment.Review of the implantation operative notes states: "we, therefore, prepared the surface going anticlockwise in the talus and clockwise in the tibia.We are able to debride appropriate surfaces.In the process however, of preparing the posterior surface of the talus, the high-speed burr cut into the peroneal tendons.These needed to be repaired".The surgical technique states "insert retractors to protect vital structures while cutting.Insert an army/navy retractor anteriorly to protect the anterior soft tissue structures.Insert posterior tissue retractor posterior to the ankle joint to protect the posterior soft tissue structures." the provided operative notes do not indicate these retractors were used to protect the tissues.Additionally the surgical technique states "cut only in a clockwise direction on the talus", and "use the same technique used for the talus, but sweep the bur in a counterclockwise direction when cutting".The provided operative notes indicate the patients bones were not prepared as specified in the technique.No other complaints of any type have been reported for the provided part numbers.This failure is the result of not performing the surgery in line with the surgical technique.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient had a hardware removal due to experiencing a partial tear of peroneal tendons in the ankle.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.The additional information received on aug 30, 2016 does not require change to the previous investigation, nor does it alter the root cause of the event.The root cause remains to be the surgeon's failure to perform the surgery with the proper technique.

• Brand Name: ZIMMER TM TIBIAL ANKLE BASE PLATE
• Type of Device: HSN
• 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: 5319627
• MDR Text Key: 34150855
• Report Number: 1822565-2015-02709
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 00830004300
• Device Lot Number: 62946242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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
• Patient Age: 73 YR
• Patient Weight: 68