MAKO SURGICAL CORP. MAKO UKR X3 ONLAY INSERT SIZE 4 - 8 MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180734-1-E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Post Operative Wound Infection (2446)
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Event Date 06/29/2023 |
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.The following devices were also listed in this report: mck femoral-rm-ll-sz 4; 180514; 615758-m, mck tibial baseplate-rm/ll-sz 4;180614 ; 26481022-01.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : device not returned.
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Event Description
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Dr.Revised a right medial uni knee to a primary all-poly cs triathlon due to infection.
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Manufacturer Narrative
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Reported event.An event regarding infection involving a mako insert 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 was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.There have been no other similar events for the sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.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.
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Event Description
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Dr.Revised a right medial uni knee to a primary all-poly cs triathlon due to infection.
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