(b)(4).Concomitant medical devices ¿ persona cemented stemmed natural tibial component size e left catalog #: 42532007101 lot #: 63189523, persona tm cruciate retaining narrow porous femoral component size 7 left catalog #: 42502206201 lot #: 63199066, persona ultracongruent vivacit-e articular surface 11 mm catalog #: 42512200511 lot #: 62335084.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.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 reports: 0002648920-2018-00622, 0001822565-2018-04158, 0001822565-2018-04159.Device remains implanted.
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