(b)(4).It is unknown which stem is implanted in the right shoulder.Lot# 214910 or 051420, sterile date: mar 31, 2011 or oct 31, 2012.Imp date: (b)(6) 2002 or (b)(6) 2002.Mfg date: mar 9, 2001 or oct 25, 2002.Medical product: bio-mod glenoid, catalog#: 113870, lot#: 690580 or 001000; bio-mod hum head, catalog#: 113760, lot#: 796750 or 961790; bio-mod centering sleeve, catalog#: 113789, lot#: 924610.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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