Catalog Number UNK_WWA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Deformity/ Disfigurement (2360); Implant Pain (4561)
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Event Date 10/13/2023 |
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 of the tibial and talar components due to pain and varus position of tibia.
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Manufacturer Narrative
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The reported event could not be confirmed, since information is not available to 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: ct scans are of insufficient quality to be reviewed by our hcp's.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 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 of the tibial and talar components due to pain and varus position of tibia.
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Search Alerts/Recalls
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