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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 ZIMMER TM TOTAL ANKLE TALAR HSN

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ZIMMER, INC. - BUILDING 5 ZIMMER TM TOTAL ANKLE TALAR HSN Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative

This report will be amended when our investigation is complete.

 
Event Description

It is reported the patient is experiencing talar component loosening following a total ankle arthroplasty where the surgeon did not fix the patient's foot deformity.

 
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. Product history search revealed no additional complaints against the related part and lot combinations. A definite root cause cannot be determined with the information provided.

 
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Brand NameZIMMER TM TOTAL ANKLE TALAR
Type of DeviceHSN
Manufacturer (Section D)
ZIMMER, INC. - BUILDING 5
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC. - BUILDING 5
1800 west center street
warsaw IN 46580
Manufacturer Contact
carrie schneider
1800 west center street
warsaw , IN 46580
8006136131
MDR Report Key5612189
Report Number0001822565-2016-01335
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00450001400
Device LOT Number62453783
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 Received08/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/29/2013
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: 04/27/2016 Patient Sequence Number: 1
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