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U.S. Department of Health and Human Services

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

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WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number SEE H10
Device Problem Material Separation
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative

The lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device. However, the suspect devices in use are part # 220220902, lot # 1466363; part # 220222206e, lot # 1475773; and part # 20034790x. The implants have 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 of total ankle. Upon explantation of the talar dome it was noticed that the plasma coating had chipped off under the surface. The patient was not adversely affected and the surgical case was not compromised in any way. Invision revision talar plate and talar dome were used as planned in the revision. Original ankle in patient for over a year.

 
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Brand NameINBONE 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 Key8479855
Report Number1043534-2019-00047
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSEE H10
Device LOT NumberSEE H10
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/17/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/03/2019 Patient Sequence Number: 1
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