STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Model Number 5532-G-313 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 07/29/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
|
|
Event Description
|
It was reported that while resurfacing the patient's native patella, the surgeon decided to revise a 3x13 ps insert to a 3x14 ps insert.
|
|
Manufacturer Narrative
|
Reported event: an event regarding revision involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photos show an explanted insert device without its locking wire.Damage is visible on the device.The damage is consistent with explantation process.Yellow discoloration is also observed on the tibial insert, the discoloration is consistent with the absorption of synovial fluid by the device.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's knee was revised to resurface the patella which was not done at the index operation.During the surgery, the tibial insert was revised a 3x13 ps insert to a 3x14 ps insert.Reason for insert revision was not reported.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
It was reported that while resurfacing the patient's native patella, the surgeon decided to revise a 3x13 ps insert to a 3x14 ps insert.
|
|
Search Alerts/Recalls
|
|
|