Catalog Number 33680014 |
Device Problem
Migration (4003)
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Patient Problems
Inflammation (1932); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 06/16/2023 |
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 due to marked anterior tibia subsidence with tibial tray tilting as well as persistent pain/swelling.
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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 due to marked anterior tibia subsidence with tibial tray tilting as well as persistent pain/swelling.
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Manufacturer Narrative
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The complaint could be confirmed, since the information for evaluation matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: the tibial component shows some anterior subsidence accompanied by a little radiolucence.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.Based on investigation, the root cause was attributed to a patient factors issue.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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