Catalog Number 5630-G-208 |
Device Problems
Device Abrasion From Instrument Or Another Object (1387); Failure to Align (2522); Material Integrity Problem (2978); Scratched Material (3020)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/14/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
When completed, the investigation results will be submitted in a supplemental report.
|
|
Event Description
|
Dr (b)(6).Had a very difficult time implanting the insert (5610-f-208) in a partial knee replacement.He tried several attempts, he made sure there was no soft tissue interfering with the insert seating.Eventually he decided to open a second insert and the new one seated right away with no challenges.
|
|
Manufacturer Narrative
|
An event regarding difficulty seating a triathlon pkr insert was reported.The event was confirmed.Method & results: -device evaluation and results: the 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.
|
|
Event Description
|
Dr (b)(6).Had a very difficult time implanting the insert (5610-f-208) in a partial knee replacement.He tried several attempts, he made sure there was no soft tissue interfering with the insert seating.Eventually he decided to open a second insert and the new one seated right away with no challenges.
|
|
Search Alerts/Recalls
|