Reported event: an event regarding disassociation, wear & metallosis involving a metal head was reported.The event was confirmed.Method & results: -product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted head covered in blood.There is nothing else to report.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless total hip arthroplasty with an accolade implant and a metal femoral head and then approximately eight years later underwent revision for trunnionosis, metallosis and had neck disassociation.I can confirm that the patient developed head neck disassociation with the above associated findings since i was able to see x-rays and gross specimens.The root cause of this event cannot be determined with certainty.The causes of trunnionosis, metallosis and head neck disassociation are multifactorial including surgical technique factors especially preparation of the trunnion and femoral head when implanted, patient factors such as activity level and bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for metallurgical analysis and examination to see if any defects were present." -product history review: device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.It was reported that the patient was confirmed due to disassociation, wear and metallosis.A review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless total hip arthroplasty with an accolade implant and a metal femoral head and then approximately eight years later underwent revision for trunnionosis, metallosis and had neck disassociation.I can confirm that the patient developed head neck disassociation with the above associated findings since i was able to see x-rays and gross specimens.The root cause of this event cannot be determined with certainty.The causes of trunnionosis, metallosis and head neck disassociation are multifactorial including surgical technique factors especially preparation of the trunnion and femoral head when implanted, patient factors such as activity level and bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for metallurgical analysis and examination to see if any defects were present." the device was not returned; however, photographs were provided for review.The photographs show a recently explanted head covered in blood.There is nothing else to report.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.
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