(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: 11-163690, m2a head, 351920, 15-103688, m2a shell, 767400, 11-103205, taperloc hip system, 171390.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 00587, 0001825034-2017-00584.
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It was reported patient had a revision procedure eleven years post-implantation due to osteolysis, metallosis, elevated metal ion levels, and pain.Additional information received in revision operative report noted corrosion material was around the metal-on-metal articulation.Corrosion was also found around the head and around the liner consistent with wear.The patient also had significant bone loss and aseptic, lymphocyte-dominated vasculitis-associated lesion (alval).Attempts have been made and additional information on the reported event is unavailable.
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