STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON SIZE 2 RIGHT CEMENTED CR FEMUR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Loss of Range of Motion (2032)
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Event Date 03/04/2024 |
Event Type
Injury
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Manufacturer Narrative
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The following devices were also listed in this report: unknown triathlon insert; cat# unknown; lot# unknown it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding range of motion (rom) involving an unknown triathlon femoral component 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: 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.
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Event Description
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It was reported that the patient's right knee was revised due to stiffness/ limited rom.A cr femur and cs insert were revised to a ps femur with augments, and a ts insert (rep confirmed that no implants were observed to be loose or malpositioned).Rep confirmed that no further information will be released by the hospital or surgeon.
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