(b)(4).Concomitant medical products: unk oxford tibial component, catalog #: unknown, lot #: unknown; unk oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00666, 3002806535-2019-00667.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.A handwritten note on the oxford partial knee warranty claim form indicates the patient was 6¿3 tall and weighed (b)(6), thus having a bmi of 27.5 (overweight).It is stated in communications with a sales representative that 'the tibia wasn¿t terribly loose but could have been the problem'.Loosening of the tibial component could not be confirmed in this instance without provision of further radiographic, patient and surgical information, as well as of the revised components.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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