WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33650005 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/04/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device remains implanted at the time of this report.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the patient underwent a total ankle replacement surgical procedure.It was reported that the patient had aseptic loosening of the tibial tray and will need a revision surgery.
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Event Description
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It was reported that the patient underwent a total ankle replacement surgical procedure.It was reported that the patient had aseptic loosening of the tibial tray and will need a revision surgery.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Radiographic images provided were not of sufficient quality for a conclusion to be made.The current instructions for use state, "dislocation and subluxation of prosthetic components can result from improper positioning and/ or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions" and "prosthetic components can loosen or migrate due to trauma or loss of fixation." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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