Catalog Number UNK_WWA |
Device Problems
Osseointegration Problem (3003); Insufficient Information (3190); Migration (4003)
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Patient Problems
Inadequate Osseointegration (2646); Insufficient Information (4580)
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Event Date 02/20/2024 |
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.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of both the tibial and talar components for reasons that are not available at the time of this report.
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of both the tibial and talar components 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 be confirmed, based on available medical record and health care professionals.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing hcp opinion and surgeon¿s feedback we can conclude that tibial component shifted anteriorly 1-2 mm and subsided as well.Loosning and migration could be confirmed for tibial component.Talar component and pe looks intact and well fixed.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by subsidence of tibial component.If the device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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