(b)(4).Concomitant devices - comprehensive segmental revision system 51mm humeral tumor body catalog #: 211221 lot #: 182240, comprehensive standard taper adaptor catalog #: 118001 lot #: 084180, comprehensive segmental revision system modular regenerex augment with screws catalog #: 211229 lot #: 916390, comprehensive reverse glenosphere catalog #: 115320 lot #: 677350.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded after it was explanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This report is number 2 of 2 mdrs filed for the same patient (reference 0001825034-2017-05383).
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