WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_WWA |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device not returned at 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 had loosening of the talus implant.No revision surgery has taken place yet.
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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.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 was not possible because the lot number was not communicated.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 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 the patient had loosening of the talus implant.No revision surgery has taken place yet.
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Search Alerts/Recalls
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