STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 03/07/2024 |
Event Type
Injury
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Event Description
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This pi is for the femoral periprosthetic fracture requiring revision.It was reported that the patient's left knee was revised due to femoral periprosthetic fracture.The patient's knee construct was revised to a distal femoral replacement.During revision, patient's blood pressure dropped.The surgery was completed and the patient closed.Patient died post-operatively outside of the o.R.(it was not reported to the rep where the patient was at time of death).Rep confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Reported event: an event regarding periprosthetic fracture involving an unknown triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral component, baseplate, and poly insert.The devices are covered in biological material.Nothing remarkable can be seen in the photographs.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 femoral periprosthetic fracture.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 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 to the manufacturer.
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