(b)(4).Additional concomitant medical products: persona uc articular surface, catalog #: 42511200412, lot #: 63551546; persona tibia, catalog #: 42532006401, lot #: 63744321; prolong nexgen patella, catalog #: 00597206626, lot #: 62257588; palacos r 1x40 single, catalog #: 00111214001, lot #: 87494700; palacos cement, catalog #: unknown, lot #: unknown.Customer has indicated product will not be returned as product remains implanted.The investigation is in process.Once the investigation is completed, a follow-up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00846, 3007963827-2019-00056, 0001822565-2019-00847, 0001822565-2019-00848.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.Device remains implanted in patient.
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