This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1, a2, a3, b4, b5, d4, g3, h2, h3, h4, h6.Complaint sample was evaluated and the reported event was confirmed.One 3/8 thd mod insert was returned and evaluated.Upon visual inspection the device had fractured at the connecting location and on one of the wings.There is no other visible damage to the device.The threaded modular inset sample revealed two fracture surfaces and sem analysis showed bending overload mode on both the fractures.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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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