It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2015 due to loosening of the femoral stem.During the procedure, the surgeon implanted the femoral stem but it did not fit well, so a larger stem was implanted.The modular head and acetabular cup were also removed and replaced.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.".
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