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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

This report will be amended when our investigation is complete.

 
Event Description

It is reported the patient is experiencing loosening of the ankle tibial component. Early on this was disabling but has lessened. She still gets a feeling of fatigue or aches with long walks. There is lucency anteriorly adjacent to the tibial component.

 
Manufacturer Narrative

No device or photos were received; therefore the condition of the component is unknown. Device history records cannot be reviewed since the part and lot number is unknown. 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 cannot be completed since the part and lot number is unknown. Patient¿s adherence to rehabilitation protocol is unknown. 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 Key5708366
Report Number0001822565-2016-01970
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2016
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 Received07/25/2016
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: 06/09/2016 Patient Sequence Number: 1
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