Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via provided photographs of the device and clinician review of provided medical records.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show that the neck of the stem has fractured.Nothing further can be observed as the device appears covered in blood.Clinician review: a review of the provided medical information by a clinical consultant indicated: "i can confirm that the patient had the primary hybrid total hip arthroplasty and sustained a prosthetic fracture of the femoral neck with a well fixed stem since i was able to review and x-ray showing the implant and fracture.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral stem fracture, approximately 15 years after implantation or multifactorial including surgical technique, especially in the way the implant was cemented (in this case it was well cemented), the patient's activity level and bmi, about which we have no information, and implant factors." 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 fracture of the exeter stem.The reported device was not returned however photographs were provided for review.The photographs show that the neck of the stem has fractured.Nothing further can be observed as the device appears covered in blood.The event was further confirmed by a review of the provided x-ray image by a clinical consultan: "i can confirm that the patient had the primary hybrid total hip arthroplasty and sustained a prosthetic fracture of the femoral neck with a well fixed stem since i was able to review and x-ray showing the implant and fracture.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of femoral stem fracture, approximately 15 years after implantation or multifactorial including surgical technique, especially in the way the implant was cemented (in this case it was well cemented), the patient's activity level and bmi, about which we have no information, and implant factors." further information such as return of the device and office notes/patient history are needed to investigate 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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