Zimmer biomet complaint (b)(4).(b)(4).Concomitant medical products: biomet microfixation tmj system cross drive emergency fossa screw 2.3 x 7 mm, catalog #: 99-6587, lot #: 626840; biomet microfixation 2.4 mm system high torque (ht) cross drive screw 2.7 x 8 mm, catalog #: 91-2708, lot #: 015140; biomet microfixation 2.4 mm system high torque (ht) cross drive screw 2.7 x 8 mm, catalog #: 91-2708, lot #: 429190; biomet microfixation tmj system right standard mandibular component 45 mm/ 7 hole, catalog #: 24-6545, lot #: 442320a; biomet microfixation tmj system right fossa component small, catalog #: 24-6562, lot #: 505150b; biomet microfixation tmj system left standard mandibular component 45 mm/ 7 hole, catalog #: 24-6546, lot #: 488250b; biomet microfixation tmj system left fossa component small, catalog #: 24-6563, lot #: 501510b.Foreign country: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00845 through 0001032347-2018-00851.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of design input forms.Functional testing and inspections could not be performed due to the parts not being returned.Per the design input form, there were plans to remove stock prostheses and replace them with a custom implant, indicating the allegation made against the stock tmj implant is confirmed.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00845-1, 0001032347-2018-00846-1, 0001032347-2018-00847-1, 0001032347-2018-00848-1, 0001032347-2018-00849-1, 0001032347-2018-00850-1, 0001032347-2018-00851-1.
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