WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33630021 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Bone Fracture(s) (1870); Swelling/ Edema (4577)
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Event Date 10/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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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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It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the patient experienced swelling of the medial ankle and was placed in a boot for 3-4 weeks.7 months later xrays and ct to evaluate pain, now shows loosening of implant.The talar component was removed.The op notes state: "it (talar component) was actually fairly well fixed, but once it was removed, we did not discover any significant growth of bone on to either the tibial side or the talar side.There was a small fracture observed within the talar neck".
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