Catalog Number 5630-G-228 |
Device Problems
Difficult to Insert (1316); Material Distortion (2977); Material Integrity Problem (2978)
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Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/10/2014 |
Event Type
malfunction
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Event Description
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It was reported that 8mm#2 insert could not be inserted again and again.Then, it was broken during medical procedure.A 9mm #2 insert could not be inserted, so #2 tibial component was removed.And, tibia was recut and #1 tibial component was implanted instead of #2 tibial component.The surgeon controlled the gap and cutting area of bone, but it was difficult to inserted and finally inserted.
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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 confirmed.Method adn results: device evaluation and results: a visual inspection showed the anterior portion of the locking feature was damaged, which would prevent it from fully seating.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 investigation concluded that the observed damage on the anterior portion of the locking feature was preventing the device from being fully seated.This damage likely occurred as a result of attempting to implant the insert while it was not fully aligned with the baseplate.
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Event Description
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It was reported that 8mm#2 insert could not be inserted again and again.Then, it was broken during medical procedure.9mm #2 insert could not be inserted, so #2 tibial component was removed.And, tibia was recut and #1 tibial component was implanted instead of #2 tibial component.The surgeon controlled the gap and cutting area of bone, but it was difficult to inserted and finally inserted.
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Search Alerts/Recalls
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