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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 33600030
Device Problem Break
Event Date 10/10/2019
Event Type  Injury  
Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

 
Event Description

Allegedly the patient underwent an ankle surgical procedure. It was reported that the screw on the adjustment block broke during use. No patient complications were reported.

 
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Brand NameINFINITY TOTAL ANKLE SYSTEM
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
matthew parrish
1023 cherry rd
memphis , TN 38117
MDR Report Key9344658
Report Number1043534-2019-00193
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number33600030
Device LOT Number1434751
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 Received10/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/03/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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