Zimmer biomet complaint (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00081, 0001032347-2021-00082, 0001032347-2021-00473, 0001032347-2021-00474.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot 531090a.Tmj system left standard offset mandibular component 45mm / 7 hole, part# 24-6646, lot# 461030a.2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot ni.2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot ni.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history records could not be reviewed as the lot numbers were unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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