MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT; ANKLE PROSTHESIS

Catalog Number 00450002500

Device Problem Insufficient Information (3190)

Patient Problems Ossification (1428); Rheumatoid Arthritis (1724); Pain (1994); Loss of Range of Motion (2032)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient experienced heterotrophic ossification of the anterior ankle; limited range of motion and impingement symptoms.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.A device history record review identified no deviations or anomalies during the manufacturing process for both tibial base and talar component.This device is used for treatment.Operative notes state that, "varus-valgus stressing as well as range of motion and stability and alignment of the construct was then confirmed under multiplanar image intensification guidance and confirmed to be appropriately positioned." initial product history search conducted on november 15th 2016 revealed no additional complaints against the related part and lot combination for both tibial base and talar component.A definite root cause cannot be determined with the information provided.

• Brand Name: ZIMMER TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
• Type of Device: ANKLE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5949268
• MDR Text Key: 54666957
• Report Number: 0001822565-2016-03260
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

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: 00450002500
• Device Lot Number: 77003657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 124