(b)(4).Concomitant medical products: biomet microfixation tmj system right standard mandibular component 45 mm, catalog #: 24-6545, lot #: 535300a; biomet microfixation tmj system right fossa component, small, catalog #: 24-6562, lot #: 532760b; biomet microfixation tmj system left standard mandibular component 45 mm, catalog #: 24-6546, lot #: 537500c; biomet microfixation tmj system left fossa component, small, catalog #: 24-6563, lot #: 539220b; biomet microfixation 2.4 mm system high torque (ht) cross-drive screw, catalog #: 91-2708, lot #: ni; biomet microfixation tmj system cross drive fossa screw, catalog #: 99-6577, lot #: ni; biomet microfixation 2.7 mm system emergency cross drive screw, catalog #: 99-9948, lot #: ni.Concomitant medical products therapy date: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient.Reported event was unable to be confirmed due to limited information received from the customer.Product identity confirmed via tmj tracking.Functional testing and inspections could not be performed due to the product not being returned and no photographs, x-rays, scans, or physician's reports being provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The instructions for use (ifu) for this product has adverse events that may occur following placement of the total tmj replacement system in the section titled adverse events: facial swelling and/or pain; loosening or displacement with or without removal of the implant; dislocation.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.There are no indications of manufacturing defects.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 reports: 0001032347-2019-00068 through 0001032347-2019-00075.
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It was reported by the patient that she is receiving treatment for her headaches in the mandibular area.The patient also reported experiencing mandibular pain, tooth pain, and spitting blood.Attempts have been made and no further information has been provided.No additional patient consequences were reported.
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