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

Catalog Number 00450005504

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/27/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent an irrigation and debridement with a poly exchange due to infection.

Manufacturer Narrative

Evaluation summary: operative notes were requested however, were not supplied.Single-use, sterilized devices manufactured or distributed by zimmer 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 device caused any patient infection.However, with the supplied information an exact cause of the reported infection could not be found.Evaluation: review of the device history records did not find any deviations or anomalies.It is not suspected that the products failed to meet specifications.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 INSERT
• Manufacturer (Section D): ZIMMER, INC.; p.o. box 708; warsaw IN 46581 070
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4641404
• MDR Text Key: 5577592
• Report Number: 1822565-2015-00414
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2015

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 00450005504
• Device Lot Number: 62557929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2015
• Initial Date FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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): Required Intervention
• Patient Age: 63 YR