WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device was not returned for evaluation.Two radiographic images were provided that depict infinity devices in-situ.It does appear to show some lucencies around the tibial tray pegs, but doesn't appear to have shifted; however, immediate postop images were not provided for comparison.
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Event Description
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It was reported that the patient underwent a total ankle replacement surgery.Allegedly, during a 3 year follow-up appointment, the patient's x-ray showed voids around the pegs of the talar implant.Physician believes that the implant may be loose.The physician does not believe it is an implant issue.The patient is a roofer and puts extreme load on the implants.
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