STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM PATELLA-SYMMETRIC; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5556-L-360 |
Device Problem
Material Deformation (2976)
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Patient Problems
Pain (1994); Joint Laxity (4526)
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Event Date 09/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding instability and wear involving a triathlon patella was reported.The event was not confirmed.Method & results: -product evaluation and results: 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: review of the device history records indicate 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 was revised due to pain and instability.Damage or 'notching' of the patellar component was also reported.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.The following devices were also listed in this report: device name#triathlon ps x3 tibial insert; cat#5532-g-709; lot#921a26.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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It was reported that the patient's right knee was revised due to pain and instability.Intra-operatively, damage to the patellar component was noted (reported as 'more like notching, like it was hitting something, than wear').The patellar component and insert were revised.Rep confirmed that no further information will be released by the hospital or surgeon.
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