WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_WWA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/21/2021 |
Event Type
Injury
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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 underwent a total ankle revisions surgery.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.
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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 (such as the reason for the revision) must be available in order to determine the root cause of the complaint event.A health care professional reviewed the ct scans and wasn't able to give a assessment on the scans due to the quality of the scans provided.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 underwent a total ankle revisions surgery.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.
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Search Alerts/Recalls
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