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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER PERSONA CEMENTED STEMMED TIBIAL PLATE

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ZIMMER PERSONA CEMENTED STEMMED TIBIAL PLATE Back to Search Results
Catalog Number 42532007501
Device Problem Failure to Adhere or Bond
Event Date 12/03/2014
Event Type  Injury  
Event Description

It is reported that the patient was revised due to loosening.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
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Brand NamePERSONA CEMENTED STEMMED TIBIAL PLATE
Manufacturer (Section D)
ZIMMER
route 1, km. 123.4, bldg. 1
turpeaux industrial park
mercedita PR 00715
Manufacturer Contact
kevin escapule
po box 708
warsaw , IN 46581-0708
8006136131
MDR Report Key4425614
Report Number2648920-2015-00010
Device Sequence Number1
Product CodeJWH
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number42532007501
Device LOT Number62268896
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/15/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/14/2015 Patient Sequence Number: 1
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