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U.S. Department of Health and Human Services

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

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 33650004
Device Problem Material Disintegration (1177)
Patient Problem Injury (2348)
Event Date 04/06/2018
Event Type  Injury  
Manufacturer Narrative

The device has been returned to the manufacturer for evaluation. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.

 
Event Description

Allegedly, the patient underwent a revision total ankle replacement; placement of cement spacer. The tibial component showed delamination of the plasma spray. No additional information is available at this time.

 
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Brand NameINFINITY®
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
1023 cherry road
memphis, TN 38117
9014516318
MDR Report Key7568773
MDR Text Key110053236
Report Number1043534-2018-00043
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK140749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number33650004
Device LOT Number1569233
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/08/2018
Event Location Hospital
Date Manufacturer Received05/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/05/2018 Patient Sequence Number: 1
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