It was reported that the patient had a right tha performed on (b)(6) 2020.The patient was doing great until she tripped on carpet at home.From the xrays she fx her femur and has a periprosthetic fracture.The surgeon wanted to remove the trilock stem and head, and put in a corail revision stem while cabling the femur.The surgeon liked the final result in regards to leg length, offset, and new stability with the corail revision stem.Doi: (b)(6) 2020, dor: (b)(6) 2020, right side.
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Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A review of a singular x-ray image does find sufficient evidence to confirm the reported bone fracture.No device error is not however identified.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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