Catalog Number 5630-G-628 |
Device Problems
Device Abrasion From Instrument Or Another Object (1387); Material Integrity Problem (2978); Positioning Problem (3009); 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 12/17/2013 |
Event Type
malfunction
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Event Description
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While doing a rt.Knee medial compartment arthroplasty using the triathlon pkr system at (b)(6), dr.Tried to implant a rt.Medial/lt.Lateral size 6 8 mm tibial bearing insert (cat #5630-g-628 lot: mlrjrk) and the implant would not lock into the baseplate adequately.The anterior/medial aspect of the bearing insert would not fully engage into the baseplate and was sitting proud and loose.After numerous attempts to reposition the implant the decision was made to remove it and put in another bearing of the same size.The second implant slid right into place, was impacted once and fully seated with minimal effort.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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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 & results: -device evaluation and results: the anterior locking features were returned damaged, confirming the event.-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 damage is likely caused by misaligning the insert with the baseplate during implantation.
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Event Description
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While doing a rt.Knee medial compartment arthroplasty using the triathlon pkr system at (b)(6), dr.Tried to implant a rt.Medial/lt.Lateral size 6 8 mm tibial bearing insert (cat #5630-g-628 lot: mlrjrk) and the implant would not lock into the baseplate adequately.The anterior/medial aspect of the bearing insert would not fully engage into the baseplate and was sitting proud and loose.After numerous attempts to reposition the implant the decision was made to remove it and put in another bearing of the same size.The second implant slid right into place, was impacted once and fully seated with minimal effort.
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Search Alerts/Recalls
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