MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM TOTAL ANKLE TIBIAL BASE

Catalog Number 00450004500

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/30/2015

Event Type  Injury  

Event Description

It is reported that the patient received a right ankle on (b)(6) 2015 and returned for an i & d due to gross infection on (b)(6) 2015.Both the tibial component and articulating poly component were revised.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Operative notes were requested however were not supplied.Single-use, sterilized devices manufactured or distributed by (b)(4) are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is highly unlikely that the specified devices caused any patient infection.However, with the supplied information an exact cause of the reported infection could not be found.Review of the device history records did not find any deviation or anomalies.These devices were used for treatment.No other complaints of any type have been reported for the lots provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

• Brand Name: ZIMMER TM TOTAL ANKLE TIBIAL BASE
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4817779
• MDR Text Key: 5928947
• Report Number: 1822565-2015-00825
• 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: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00450004500
• Device Lot Number: 62622282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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
• Treatment: LOT #62565892, CATALOG #00110100200, LOT #62793899; OSTEOBOND COPOLYMER BONE CEMENT
• Patient Outcome(s): Required Intervention