STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON RIGHT KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 03/29/2023 |
Event Type
Injury
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Event Description
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This pi is for the right knee.Patient reported that she had a triathlon primary right knee replacement in (b)(6) 2015.Patient states that she has experienced pain since the surgery and had to have the "internal" sutures removed from the thigh in 2017 due to the sutures becoming "inflamed" patient also reported having had a revision done in 2019 to have her "pad" replaced.
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Manufacturer Narrative
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Reported event: an event regarding revision involving an unknown triathlon knee 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: 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.The reason for revision was not 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.Device not returned.
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Search Alerts/Recalls
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