WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ BIOFOAM¿ 3D; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33680033 |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device remains implanted in the patient.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 a crack in the anterior lateral talar peg was found at the patient's 11 month (approx) follow up.No revision has been scheduled at this time.
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Manufacturer Narrative
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The reported event could be confirmed, since one radiographic image was provided evaluation and matches the alleged failure.The device inspection revealed the following: from review of the image it appears the talar dome has fractured and migrated posteriorly.Based on the image alone, the reason for implant breakage could not be determined.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.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that a crack in the anterior lateral talar peg was found at the patient's 11 month (approx) follow up.No revision has been scheduled at this time.
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Search Alerts/Recalls
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