MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 ZIMMER TM TOTAL ANKLE TALAR HSN

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient is experiencing talar component loosening following a total ankle arthroplasty where the surgeon did not fix the patient's foot deformity.

Manufacturer Narrative

No device or photos were received; therefore the condition of the component is unknown. Review of the device history records did not find any deviations or anomalies. This device is used for treatment. Product history search revealed no additional complaints against the related part and lot combinations. A definite root cause cannot be determined with the information provided.

• Brand Name: ZIMMER TM TOTAL ANKLE TALAR
• Type of Device: HSN
• Manufacturer (Section D): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5612189
• MDR Text Key: 43794318
• Report Number: 0001822565-2016-01335
• 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: DISTRIBUTOR,HEALTH PROFESSION

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 04/27/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: N/A
• Device Catalogue Number: 00450001400
• Device LOT Number: 62453783
• OTHER Device ID Number: N/A
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/29/2013
• 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 TREATMENT DATA

Date Received: 04/27/2016 Patient Sequence Number: 1