Catalog Number UNK_OFL |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 02/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.Device not returned.
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Event Description
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It was reported that the patient's right mako knee was revised due to infection.A washout and revision of a 6x9 cs poly was performed.Rep provided usage sheets for the primary and prior revision and may be able to provide the latest usage sheet, and reported that otherwise, no further information will be released.
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Manufacturer Narrative
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Reported event: an event regarding other involving a mako tka software was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: review of the case session files was not performed as case session data was not provided.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a review of device history records shows that rob576 was inspected on 23 may 2017 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: rob576 shows 0 similar complaints for tka software - other (infection).Conclusions: all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not available.
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Event Description
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It was reported that the patient's right mako knee was revised due to infection.A washout and revision of a 6x9 cs poly was performed.Rep provided usage sheets for the primary and prior revision and may be able to provide the latest usage sheet, and reported that otherwise, no further information will be released.
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Search Alerts/Recalls
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