(b)(4).Concomitant medical products: comp primary stem 11mm mini, cat#: 113631 lot#: 652380; md hybrid glenoid base 4mm, cat#: 113954 lot#: 019410; pt hybrid glen post regenerex, cat#: pt-113950 lot#: 195880; versa dial/comprehensive std t pr adaptor, cat#: 118001 lot#: 603610; cobalt hv bone cement 40g, cat#: 402282 lot#: 780720; optivac kit 40gram single mix, cat#: 417100 lot#: 698023; 1/8 quick rel drl sterile 2pk, cat#: 32-486265 lot#: 357110; gps iii single kit w/30ml acda, cat#: 800-1003a lot 069871; biomet biologics spray kit, cat#: 800-0250 lot#: 109501; gps dual spray applicator tip, cat#: 800-0201 lot#: 107511.Customer has indicated that the product will not be returned (as it remains implanted) to zimmer biomet for investigation.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: 1825034-2017-01417 ¿ 01421.
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This follow-up report is being submitted to relay corrected and additional information.Device was not returned for analysis; therefore, a product evaluation could not be conducted.Dhrs were reviewed and no discrepancies were found.Review of the complaint histories determined that no further action is required as no were trends identified.Root cause was undetermined.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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