MAUDE Adverse Event Report: ZIMMER, INC. TRABECULAR METAL ANKLE TIBIAL BASE; HSN

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a patient was experiencing ankle pain, and then later revised due to pain and tibial ankle implant loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

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.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Product history search revealed no additional complaints against the related part and lot combination.Patient¿s activity level and adherence to rehabilitation protocol is unknown.A definite root cause cannot be determined with the information provided.

• Brand Name: TRABECULAR METAL ANKLE TIBIAL BASE
• Type of Device: HSN
• 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: 5666654
• MDR Text Key: 45509612
• Report Number: 0001822565-2016-01616
• 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,Followup
• Report Date: 02/04/2016

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 Model Number: N/A
• Device Catalogue Number: 00450004400
• Device Lot Number: 62876090
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/15/2016; 08/08/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 116