Product complaint #: (b)(4).Investigation summary: examination of the returned instrument partially confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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The primary surgery was performed on an unknown date via tha.It was reported that the revision surgery was performed on (b)(6) 2020.The reason of the revision surgery is the cup sinking to the acetabular.The fixation of the stem was good, but it was removed because it interrupted to remove the cup.During the surgery, when the surgeon set a cone reamer to the extension reamer hudson, attached them to a power tool and checked the action, the rotation was eccentric.The surgeon used the devices to drill the femoral medullary cavity, the surgeon had a risk to break the femur due to the device¿s eccentric rotation.He proceeded with the procedure carefully and as a result the duration of the surgery was extended about less than 30 minutes.The feared event did not happen.No further information is available.
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