An event regarding a periprosthetic fracture involving an unknown accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, dimensional and functional inspection was not performed as the device was not returned for evaluation.-medical records received and evaluation: a review of the provided medical records indicated: "there is no evidence available in the current case to suggest that device-related issues have played a role while the discussed adverse mix of patient- and procedure-related factors should be considered more than adequate to have caused the periprosthetic fracture problem in this patient.This case is not device-related.Diagnosis: - an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture requiring revision surgery." -device history review could not be performed as the device lot is unknown.-complaint history review could not be performed as the device lot is unknown.Conclusions: a medical review was completed and diagnosed that "an adverse mix of patient-related (osteoporosis) and procedure-related factors (surgical preparation in osteoporotic bone) have caused a peri-prosthetic fracture requiring revision surgery" further information however such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
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