(b)(4).Concomitant products: 00801803201 ¿ cocr head ¿ 60939983; 00771100900 ¿ m/l taper stem ¿ 60939440; 00625006530 ¿ bone screw- 60875832; 00625006525 ¿ bone screw - 60740475; 00630505632 ¿ liner ¿ 60918074.Medical records were reviewed by an hcp and notes revision due to pain.Pseudocapsule in the joint and corrosion at the trunnion and screw holes of the shell.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2021 - 00310, 0001822565 - 2021 - 02832, 0002648920 - 2022 - 00022, 0002648920 - 2022 - 00023.
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It was reported patient underwent a right hip revision approximately 12 years post implantation due to pain.During the surgery a pseudocapsule was encountered, gross corrosion was noted at the trunnion and acetabulum components, and the gluteus medius damaged from previous surgery.The head and liner were removed and replaced without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
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