It was reported that about 20years before now, on an unknown date, the primary surgery was performed via tha with the liner, head and wire in question.On an unknown date, it was confirmed that the wire, which was used around the femur, had been broken, and the pus was spreading, and the patient felt pain due to this event on the right side.On (b)(6) 2021, the revision surgery will be performed replacing the liner and head.On (b)(6) 2021, the revision surgery was performed.Before entering the room, the patient was already bleeding at her femoral shaft part, and her femur was covered with gauze.After the surgeon made an incision, he cut the cables and removed them with a pliers.And he removed the head and tried to remove the liner, but he had difficulty in removing the liner with the removal instruments.Finally, he broke the liner with a chisel and remove the liner.He implanted new head and liner and closed the incision.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
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