(b)(4).Concomitant products: unknown hybrid glenoid cat#ni lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Sperling, john w, marigi, erick m, lenartowicz, karina a, jennewine, brenton, throckmorton, thomas w.(2022) clinical and radiographic outcomes of hybrid glenoid fixation with a central porous titanium post: analysis of 713 consecutive shoulders, journal of shoulder and elbow surgery.Https:// doi.Org/10.1016/j.Jse.2021.12.033.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00617.
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It was reported in a journal article from the journal of shoulder and elbow surgery, which studied patient outcomes after primary elective hybrid total shoulder arthroplasties, that patient underwent reoperation or revision due to arthrofibrosis.Attempts have been made and additional information on the reported event is unavailable at this time.
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This follow-up report is being submitted to relay additional information.Upon further review, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet devices.Arthrofibrosis is a condition of the knees that may cause pain, stiffness, and limited range of motion.This is due to scar tissue and/or contractures that develop within the knee joint after surgery or an untreated injury.Treatment may include physical therapy, manipulation under anesthesia or arthroscopy in which the scar tissue is removed.
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