Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation 1.5mm x 3.5mm ht sd x-dr screw catalog #: 91-6103 lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient.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 report: 0001032347-2018-00223.
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The patient had these implants for more than three years, had an mri on (b)(6) 2018, and developed fluid buildup underneath her plate six days later on (b)(6) 2018.However, the patient did not receive any additional therapy or surgery, and a definitive cause could not be determined by her physicians.The implants remain implanted; therefore, functional testing and inspections could not be performed.There was limited information provided and no materials such as photographs, scans, x-rays, or physician's reports were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00223-1.
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