STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON 6X9 CS INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Catalog Number UNK_JR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 03/13/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Reported event: an event regarding infection involving an unknown triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision 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.H3 other text : device not returned.
|
|
Event Description
|
It was reported through the submission of a revision usage sheet that the patient's left knee was revised.A triathlon 6x9 cs insert was implanted.Update 14/march/2024 wg: additional information provided by rep: the patient had some drainage from his previous incision & appeared to possibly be infected.The doctor removed #6 9mm cs insert & replaced it with the new, but same size #6 9mm insert.The implant that was removed was not avail to be sent back to stryker per hospital policy.
|
|
Search Alerts/Recalls
|
|
|