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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. TRABECULAR METAL ANKLE TIBIAL BASE HSN

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ZIMMER, INC. TRABECULAR METAL ANKLE TIBIAL BASE HSN Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond
Event Date 05/09/2016
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported that a patient was experiencing ankle pain, and then later revised due to pain and tibial ankle implant loosening.

 
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Manufacturer Narrative

No device or photos were received; therefore the condition of the component is unknown. Review of the device history records did not find any deviations or anomalies. This device is used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. Product history search revealed no additional complaints against the related part and lot combination. Patient¿s activity level and adherence to rehabilitation protocol is unknown. A definite root cause cannot be determined with the information provided.

 
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Brand NameTRABECULAR METAL ANKLE TIBIAL BASE
Type of DeviceHSN
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 Key5666654
Report Number0001822565-2016-01616
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/19/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00450004400
Device LOT Number62876090
OTHER Device ID NumberN/A
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 Received07/25/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2014
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: 05/19/2016 Patient Sequence Number: 1
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