Model Number 6197-9-001 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pulmonary Edema (2020); Embolism/Embolus (4438)
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Event Date 04/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Tha with stryker devices were performed after removal of the gamma type made by mdm (b)(4).After insertion of the exeter, the patient's blood pressure and saturation did not rise, and pulmonary embolus was suspected.The surgery was not interrupted and was continued to the end.The patient's condition is unknown.
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Manufacturer Narrative
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An event regarding patient factors involving a simplex cement mix was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: no medical records were provided for review with clinical consultant.-product history review: review of the device history records indicate packs were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays, patient history and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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Event Description
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Tha with stryker devices were performed after removal of the gamma type made by mdm japan.After insertion of the exeter, the patient's blood pressure and saturation did not rise, and pulmonary embolus was suspected.The surgery was not interrupted and was continued to the end.The patient's condition is unknown.
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Search Alerts/Recalls
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