(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-03675, 0001822565-2023-03676, 0001822565-2023-03677.D10-medical product: unknown nexgen stemmed tibia, unknown nexgen stubby stem, unknown nexgen cr poly liner.G2- australia.H3- 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.
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This follow-up is being submitted to relay additional information.Development of a cyst is a non-procedural or implant related event, that can occur at any time during a person¿s lifetime regardless of a surgical procedure or implant.Cysts are abnormal, closed sac or capsule like structures within tissue or bone that can present with varying size, shape, and consistency, such as gas, fluid, or semisolid.They can resolve without medical intervention, as the body simply absorbs them, or they can require medical intervention.Treatment can include needle aspiration, injection of steroids, as well as surgical removal.Symptoms a patient can experience include pain, swelling, alteration in sensation, limitation of joint mobility, and weakness.If any further information is received 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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