Catalog Number 33680021 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Limb Fracture (4518)
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Event Date 01/25/2024 |
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 removal surgery of the current talar implant due to early collapse of the tibial side without trauma.There is a fracture present in the tibia.The physician reported that the patient will need intramedullary fixation.
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Manufacturer Narrative
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The reported event could not be confirmed, confirmed based on available ct scans and medical expert assessment.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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: "subsidence and loosening of the tibial tray due to poor bone quality and a fracture of the tibial plafond, thus patient related.No early postoperative x-ray for comparison.Components as such intact".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 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 removal surgery of the current talar implant due to early collapse of the tibial side without trauma.There is a fracture present in the tibia.The physician reported that the patient will need intramedullary fixation.
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Search Alerts/Recalls
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