(b)(4).Foreign: (b)(6).Concomitant medical products: persona partial femur cemented cat#: 42558000302, lot#: 63760813, persona partial articular surface cat#:42528200508, lot#: 63449777.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.Multiple mdr reports were filed for this event, please see associated reports:0001822565 - 2018 - 05937, 0001822565 - 2018 - 05938, 0001822565 - 2018 - 05939.Product remains implanted.
|