(b)(4).Concomitant medical products: ml-hd mod calc prox 34b part 108112 lot 940540, r/h m/h 13x220 80%(165) distal part 11-108253 lot 232980, 36 mm cocr mod hd std part 11-363662 lot 096120, m/h 3hole rlc shl nrs 58 mm/l25 part 13-104158 lot 081530, arcomxl 36 mm rlc lnr hw sz25 part xl-105915 lot 054370, cocr cable sleeve 2.0 mm part 120005 lot 777870, cocr troch cable 2.0 mm x 750 mm part 120002 lot 857330, cocr troch cable 2.0 mm x 750 mm part 120002 lot 107110.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06925-1, 0001825034-2018-06942-1, 0001825034-2018-06932-1, 0001825034-2018-06940-1, 0001825034-2018-08983, 0001825034-2018-08985, 0001825034-2018-08986, 0001825034-2018- 08987, 0001825034- 2018-08988, 0001825034-2018-08989, 0001825034-2018-08991, 0001825034-2018-08992.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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