(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional concomitant medical products: tibial articular surface provisional shim size ef 11 mm item # 42527900501 lot # 62710614; tibial articular surface provisional shim size cd 14 mm item # 42527900304 lot # 62414007; tibial articular surface provisional shim size gh 12 mm item # 42527900702 lot # 62220948; tibial articular surface provisional shim size gh 14 mm item # 42527900704 lot # 62784389.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00671, 0001822565-2019-00672, 0001822565-2019-00673, 0001822565-2019-00674.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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