An event regarding periprosthetic fracture involving a exeter stem was reported.The event was confirmed by clinician review.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: the available medical records were provided to the consulting clinician for a review which was rejected stating, "re pi: which represents an 86 y/o male patient who underwent a hybrid tha in 2008.Event description states: "periprosthetic fracture.Exeter trident hip implanted in 2008.Appears to be from trauma." undated x-ray ap left hip exeter hybrid tha, no screws in uncemented acetabular component reduced, cemented stem, nominal and well fixed components, comminuted displaced periprosthetic femoral fracture beginning at the junction of the mid and distal third of the stem and continuing distally beyond the view of the x-ray.The x-ray confirms the event description, but insufficient data present to create a report on this case." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient had a periprosthetic fracture.The available medical records were provided to the consulting clinician for a review which was rejected for a review stating that the x-ray confirms the event description, but insufficient data present to create a report on this case.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 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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