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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN ZIMMER TIBIAL COMPONENT ANKLE PROSTHESIS

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ZIMMER, INC. UNKNOWN ZIMMER TIBIAL COMPONENT ANKLE PROSTHESIS Back to Search Results
Device Problem Failure To Adhere Or Bond
Event Type  Injury  
Manufacturer Narrative

Information was received via journal article. Please reference literature at the following location: (b)(4). This report will be amended when our investigation is complete.

 
Event Description

It is reported that two patients were experiencing loosening around the anterior rail guide of the tibial prosthesis at 12 months. Both patients were asymptomatic.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. No device or photos were received; therefore the condition of the device is unknown. Device history records cannot be reviewed since the lot number is unknown. This device is used for treatment. A product history search cannot be completed since the lot number is unknown. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. A definite root cause cannot be determined with the information provided.

 
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Brand NameUNKNOWN ZIMMER TIBIAL COMPONENT
Type of DeviceANKLE PROSTHESIS
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 Key5882207
Report Number0001822565-2016-02848
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/17/2016 Patient Sequence Number: 1
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