Catalog Number UNK_WWA |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Insufficient Information (4580)
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Event Date 02/06/2024 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition unknown.
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient underwent a device explant surgery for reasons that are not available at the time of this report.The patient received a cement spacer.
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Manufacturer Narrative
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Correction - h6 (results code).The reported event that could not be confirmed, based on available medical records and assessment of 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: after reviewing hcp opinion and surgeon¿s feedback we can conclude that there is gridle stone situation with cement spacer is visible in ct scans.Infection may be the possible cause of implant removal and insertion of cement spacer in cavity.Hence, without further clinical information assessment is not possible.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 underwent a device explant surgery for reasons that are not available at the time of this report.The patient received a cement spacer.
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Search Alerts/Recalls
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