WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TALAR DOME SZ 1 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33630021 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device not returned 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.Sometime post-op it was discovered that the patient may need to undergo a revision surgery for reasons that were not reported at the time of this report.
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Event Description
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It was reported that the patient underwent a total ankle replacement surgical procedure.Sometime post-op it was discovered that the patient may need to undergo a revision surgery due to pain that occurred sometime post-op.
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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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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