It was reported patient is experiencing pain, bursitis and tendonitis four months post implantation due to a fall.Radiographically, implants remain intact, in stable position, and with no evidence of loosening or wear.Attempts to obtain additional information have been made; however, no more is available.
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(b)(4).Medical product: femur cemented plus right size 7+ item # 42504606212 lot # 64566646.Stem extension 3mm offset splined uncemented item # 42560313517 lot # 64578342.Tibia fixed cemented right size e stem extension item # 42542007102 lot # 64318491.Stem extension tapered cemented item # 42560007514 lot # 64630443.Tibial augment cemented half block item # 42555805405 lot # 64499789.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2022-03311, 0001822565-2022-03312, 0001822565-2022-03313, 0001822565-2022-03314, 0001822565-2022-03315.
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 reported event was confirmed by review of medical records provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Medical records review indicates that office visit had a few falls and is now having pain, x-ray: no acute fractures or dislocations, implant remain in good position.X-rays: stable position, no loosening or wear, was falling once a week, steroid injection for pes bursitis, knee pain improved but now has back pain, 60 percent improvement with knee pain, rom: 0-125 degree, tenderness to midline joint, immediate discomfort with extension, mild swelling if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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