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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,

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WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM PROSTHESIS, ANKLE, SEMI-CONSTRAINED, Back to Search Results
Model Number 33630022
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Tissue Damage (2104)
Event Date 01/03/2017
Event Type  Injury  
Manufacturer Narrative
The parts were returned for evaluation. Overall, the poly insert and tibial tray did not show any gross deformation. Visual examination of all the devices showed a few gouge marks and heavier scratches/dings, which are consistent with removal during the revision surgery. Visual examination the porous surface of the talar dome and tibial tray does exhibit a few areas of apparent bone attachment. Finally, examination of the talar dome found that some of the plasma spray is missing.
 
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, it was reported that the patient was scheduled for a calcaneal osteotomy. It was reported that during incision, it was discovered the patient could possibly have an infection. Tissue cultures confirmed the infection, so all of the ankle replacement implants were removed from the patient. The implant appeared to "stuck" to the patient's bone. Therefore, the bone was peeled off of the talus and tibial components. Surgeon created an antibiotic cement spacer. No additional patient complications were reported.
 
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Brand NameINFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED,
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
tim nickel
1023 cherry road
memphis, TN 38117
901451-631
MDR Report Key6258569
MDR Text Key111225570
Report Number1043534-2017-00004
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number33630022
Device Lot Number1556327
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/04/2017
Event Location Hospital
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/17/2017 Patient Sequence Number: 1
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