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 04/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device had not been returned as it is still in the patient.If additional information becomes available, it will be provided on a supplemental report.Device not available remains implanted.
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Event Description
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It was reported that the patient underwent a total ankle replacement surgery.Sometime post-op it was reported the patient will need to undergo a revision surgery for reasons that were 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.The radiographic images provided were not of sufficient quality for a conclusion to be drawn.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.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.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 replacement surgery.Sometime post-op it was reported the patient will need to undergo a revision surgery for reasons that were not available at the time of this report.
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Search Alerts/Recalls
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