INFINITY TOTAL ANKLE SYSTEM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for INFINITY TOTAL ANKLE SYSTEM UNK manufactured by Wright Medical Technology, Inc..

Event Text Entries

[188208357] Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


[188208358] It was reported that the patient underwent a total ankle replacement. Allegedly, sometime post-op it was found that the patient will need to undergo a revision surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1043534-2020-00055
MDR Report Key9853457
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-19
Date of Report2020-02-19
Date of Event2020-02-19
Date Mfgr Received2020-02-19
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR MATTHEW PARRISH
Manufacturer Street1023 CHERRY RD
Manufacturer CityMEMPHIS TN 38117
Manufacturer CountryUS
Manufacturer Postal38117
Manufacturer G1WRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Street11576 MEMPHIS ARLINGTON RD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINFINITY TOTAL ANKLE SYSTEM
Generic NamePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Product CodeHSN
Date Received2020-03-19
Model NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Address11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-19

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