WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY(R) TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number SEE H10 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Inflammation (1932)
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Event Date 09/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 #33630022, lot # 1583969 and part # 33653206, lot # 1561610.Manufacture date for lot 1583969 is 11/07/2016; manufacture date for lot 1561610 is 07/14/2015.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Event Description
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Allegedly, the patient had cysts anterior and posterior at tibial component, but no signal on spect.Inflammation mainly anteromedial and posteromedial at talus.Revised to inbone talus (size 3) with infinity poly size 3 (6mm).Tibia was observed to have solid fixation and was not revised.
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