STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 1 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531-G-109-E |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Loss of Range of Motion (2032); Scar Tissue (2060)
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Event Date 02/20/2024 |
Event Type
Injury
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Event Description
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Right knee scar tissue and pcl resection with a tibial insert exchange due to lack of range of motion.
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Manufacturer Narrative
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Reported event: an event regarding range of motion (rom) involving a triathlon insert 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.Device 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 limited range of motion.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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
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Search Alerts/Recalls
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