STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Catalog Number 5515-F-501 |
Device Problem
Sticking (1597)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/12/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Only pacaging was returned, device was implanted.When completed, the investigation results will be submitted in a supplemental report.
|
|
Event Description
|
The #5 lt femoral component stuck in both sterile packages.Delay of surgery was 5 min.
|
|
Manufacturer Narrative
|
An event regarding packaging issue involving a triathlon ps fem component, cemented was reported.The event was not confirmed.Method & results: -device evaluation and results: the packaging box with a shrink wrap partially open, package insert, tyvek lid of the outer blister and the ifu were returned.The implant, tyvek lid of the inner blister and the foam was not returned.However, there is evidence that there was a seal in the inner and outer blisters.The packaging box and outer sterile packaging looks remarkable.The inner sterile packaging looks as if it was pushed inside out.-medical records received and evaluation: not performed as medical records were not provided for review.-device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: no other events were reported for the lot indicated.Conclusions: the exact cause of the event could not be determined because the packaging was returned without the implant.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
|
|
Event Description
|
The #5 lt femoral component stuck in both sterile packages.Delay of surgery was 5 min.
|
|
Search Alerts/Recalls
|
|
|