An event regarding periprosthetic fracture involving an unknown accolade stem was reported.The event was 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 x-ray by a clinical consultant indicated."this would leave an external trauma of the patient as the most likely cause of the problem.Even though trauma was not reported, both timing and type of fracture are thus consistent with an external trauma of the patient at a time when bone ingrowth fixation was already completed." "procedure-related factors: none.Patient-related factors: patient trauma.Device-related factors: none.Diagnosis: a traumatic overload condition has contributed to a periprosthetic fracture around the accolade ii stem requiring revision." 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: the exact cause of the event could not be determined nor the root cause confirmed however a review of the medical records by a clinical consultant indicated that "this would leave an external trauma of the patient as the most likely cause of the problem.Even though trauma was not reported, both timing and type of fracture are thus consistent with an external trauma of the patient at a time when bone ingrowth fixation was already completed." further information such as device details, return of device, operative reports, & 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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