Zimmer biomet complaint (b)(4).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: 0001032347-2020-00490, 0001032347-2020-00491, 0001032347-2020-00492, 0001032347-2020-00493, 0001032347-2020-00495.Medical products: tmj system right fossa component, small, part# 24-6562, lot# 688990b.Tmj system right standard titanium mandibular component 45mm / 7 hole, part# 24-6545ti, lot# 828150c.2.4mm system high torque (ht) cross-drive screw 2.7 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.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Tmj system cross drive fossa screw 2.0mm x 11mm, part# 99-6581, lot# ni.Occupation: patient.
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It was reported the patient underwent a revision to remove temporomandibular joint implants on the right side due to allergic reaction eight (8) months following implantation.The patient reports there was an allergy test prior to implantation that confirmed a nickel allergy but there was no indication of a titanium allergy at that time.One (1) month following implantation, the patient experienced redness, itching and hives on the jaw, ear, throat and neck.A titanium allergy was confirmed approximately two (2) months following implantation.The patient was prescribed nine (9) medications to treat a reported facial infection.The patient is currently on iv medication for eight (8) weeks following an eye reaction that occurred following the removal of the implant.The patient is discussing implant replacement options with their surgeon.No additional patient consequences have been reported.
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for the screws involved in this case.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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