Catalog Number 5630-G-120 |
Device Problems
Device Abrasion From Instrument Or Another Object (1387); Fitting Problem (2183); Material Integrity Problem (2978); Scratched Material (3020)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/27/2015 |
Event Type
malfunction
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Event Description
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During a right primary pkr uni knee procedure, the surgeon was unable to fully seat the insert.A backup was immediately available and the surgery was completed successfully.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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An event regarding difficulty seating a triathlon pkr insert into a baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: a functional inspection indicated the device is fully functional.Medical records received and evaluation: not performed as patient factors did not contribute to the event.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar reported events for this lot id.Conclusions: the reported event could not be replicated nor confirmed as the device was determined to be fully functional.It is likely the user attempted to implant the insert while misaligned with the baseplate.
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Event Description
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During a right primary pkr uni knee procedure, the surgeon was unable to fully seat the insert.A backup was immediately available and the surgery was completed successfully.
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Search Alerts/Recalls
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