(b)(4).(udi): n/a.Medical product: catalog #: 180151, maestro rad w/brg 7x15 7.5 rt, lot # 922440; catalog #: 180351, variable lock screw 4.75x20mm, lot # 748570; catalog #: 180363, maestro tc carpalhd 7x15mm std, lot # 527190; catalog #: 180352, variable lock screw 4.75x25mm, lot # 551330; catalog #: 180363, maestro tc carpalhd 7x15mm std, lot # 527190; catalog #: 180321, maestro tc capitatestem 6x15mm, lot # 238690.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.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.Unknown if product will be returned.
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(b)(4).Reported event was considered confirmed due to the proved x-rays that showed loosening of the radial component.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was considered to be user error as it was known that the patient was a nurse that lifted patients.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: 0001825034-2019-05314.
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