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 05/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.Should additional information become 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 surgery.Allegedly, the patient may need to undergo a revision surgery.
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Manufacturer Narrative
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The complaint could be confirmed, since the returned image for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: the ct-simulations show an anteriorly subsided tibial baseplate.However, due to lack of further information no root cause can be assessed.The implant is not shown.The ct-simulation show a normal relationship between the components, thus making pe-problems unlikely.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.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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.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.Allegedly, the patient may need to undergo a revision surgery.
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Search Alerts/Recalls
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