STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5521-B-600 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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Primary knee, rep was not present for the procedure.It was reported that the surgeon did not like how the 'nub' engaged with the baseplate threads.Surgeon elected not to implant the device.Another device (same catalog, different lot) was opened and performed as expected.Surgery completed successfully.No delay was reported.
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Event Description
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Primary knee, rep was not present for the procedure.It was reported that the surgeon did not like how the 'nub' engaged with the baseplate threads.Surgeon elected not to implant the device.Another device (same catalog, different lot) was opened and performed as expected.Surgery completed successfully.No delay was reported.
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Manufacturer Narrative
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Reported event: an event regarding an alleged seating/locking issue involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual inspection showed no signs of use or abuse, nor any signs of any abnormalities.A functional inspection was performed where the end cap and baseplate were assembled by a trained operator.The torque wrench gage reading was within the requirement and the assembled components were deemed acceptable.-medical records received and evaluation: not performed as medical records were not received for review with a clinical consultant.-device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been no other similar events reported for this manufacturing lot.Conclusions: the returned baseplate was functionally inspected to be within specification and functionally tested to perform satisfactorily.There is no indication the event is related to a manufacturing issue.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
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Search Alerts/Recalls
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