(b)(4).Concomitant medical products: item 00575201501 lot 64169588.Item 90597003010 lot 64198343.Item 00597206532 lot 64143810.Report source: foreign (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00294, 0001822565-2021-00295.
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(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g4, g7, h1, h2, h3,h6, h10.This complaint was not confirmed as official medical records were not provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Joint assist records were provided and reviewed by a health care professional.Review found at 1 year visit patient had difficulty ambulating and stiffness.Patient had mua and was resolved.Further medical records were not provided.A definitive root cause cannot be determined.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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