(b)(4).Device was cleaned with betadine solution and re-implanted.Concomitant medical product: oss tibial poly bearing cat#:150410, lot#:701360.Oss segmental femoral cat#:150355, lot#: 919810.Oss poly tibial bushing cat#: 150368, lot#: 691040.Oss poly femoral bushings cat#: 150477, lot#: 067100.Oss poly lock pin cat#: 150478, lot#: 446190.Oss axle cat#: 150480, lot#: 146210.Oss reinforced yoke cat#: 150493, lot#: 918850.Oss ellip diaphyseal seg cat#: 150461, lot#: 755520.Oss non-mod tib plate long 63 cat#: 150419, lot#: 612080.Oss tib blk aug 10x63/67 univ cat#: 150426, lot#: 896800.Oss tib blk aug 10x63/67 univ cat#: 150426, lot#: 015450.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, 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.0001825034 - 2017 -1164, 0001825034-2017-02326, 0001825034-2017-02326-1, 0001825034-2017-02326-2, 0001825034 -2017 -1168.Remains implanted.
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