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U.S. Department of Health and Human Services

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

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ZIMMER, INC. ZIMMER TM TOTAL ANKLE TIBIAL INSERT Back to Search Results
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.
 
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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 Key4641404
MDR Text Key5577592
Report Number1822565-2015-00414
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Date11/30/2018
Device Catalogue Number00450005504
Device Lot Number62557929
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/23/2015
Initial Date FDA Received03/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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