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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Device Problem Appropriate Term/Code Not Available
Event Date 02/23/2017
Event Type  Injury  
Manufacturer Narrative

The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device. Part # 33630022, lot 1581431; part # 33650002, lot 1583031; part # 33652206, lot 1541546. Part # 33630022, lot 1581431 is 09/28/2016; part # 33650002, lot 1583031 is 09/26/2016; part # 33652206, lot 1541546 is 05/01/2014. Eval: varus failure. 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

It was reported that 2 months prior to total ankle replacement surgery, the patient had increased ankle pain. The patient had remote history of right ankle fractures. After conservative treatment failed, the patient underwent surgery. A few weeks after surgery, it was noticed that the ankle had increased swelling and edema. Two months post-op, varus fail of implant and a medial mal fracture were noted on films. The dpm called it a stress riser medial mal fracture. Three months post-op, the patient underwent an orif to treat the medial mal fracture. The dpm suggested on op notes that the fracture was a result from rom with physical therapy.

 
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Brand NameINFINITY® TALAR DOME SZ 2 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
1023 cherry road
memphis , TN 38117
9014516318
MDR Report Key7112911
Report Number1043534-2017-00116
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/15/2017
Event Location Home
Date Manufacturer Received11/15/2017
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?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/13/2017 Patient Sequence Number: 1
Treatment
POLY
TALAR DOME
TIBIAL TRAY
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