Catalog Number 33650014 |
Device Problems
Osseointegration Problem (3003); Migration (4003)
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Patient Problems
Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Implant Pain (4561)
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Event Date 11/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in 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.The physician noted that the tibial component has subsided.The patient has continued pain and limited range of motion.
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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.The physician noted that the tibial component has subsided.The patient has continued pain and limited range of motion.
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Manufacturer Narrative
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The reported event could not be confirmed due to the lack of additional clinical information.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿there is no clear radiolucence and no cysts around the implant therefore loosening or subsidence cannot be confirmed with the given ct.The surgeon assumes that the components could be loose.This cannot be confirmed with certainty using the ct images.As a certain amount of pain and restricted movement are described as the main clinical symptoms, i believe that a soft tissue problem could also be the cause of the pain/reduced range of motion.¿ 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.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.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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