Catalog Number 33680013 |
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 02/14/2024 |
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.H3 other text : device remains implanted in patient.
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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 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.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.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 subsidence and loosening of the tibial tray due to poor bone quality.Pe looks intact with tibial tray and talar dome.Talar component also looks intact.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by subsidence of tibial component due to poor bone quality.If the device is returned or any further information is provided, the investigation report will be reassessed.
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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 for reasons that are not available at the time of this report.
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Search Alerts/Recalls
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