Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00515, 0001032347-2020-00516, 0001032347-2020-00517, 0001032347-2020-00518, 0001032347-2020-00519, 0001032347-2020-00520, 0001032347-2020-00521.Medical products: tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 670470c.Tmj system left fossa component, small, part# 24-6563, lot# 726860a.Tmj system right narrow mandibular component 45mm / 6 hole, part# 01-6545, lot# 710700b.Tmj system right fossa component, large, part# 24-6564, lot# 602100b.2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, 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 9mm, part# 99-6579, lot# ni.Occupation¿ patient.
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It was reported the patient has experienced multiple issues following implantation of bilateral temporomandibular joint implants three (3) years ago.Immediately following implantation, the patient developed bell¿s palsy on the right side and was informed by the surgeon that it was a possible reaction to the surgery.The patient has used a bite splint for three (3) years to align the bite.The patient had a root canal a couple months ago and the endodontist took cone beam imaging.Based on the imaging, the endodontist believes the device is rubbing the bone and that the splint increases the pain.The patient has an unspecified one (1) inch deformity in the jaw.The patient underwent a dry needling treatment one (1) year ago that did not provide adequate pain relief.The patient wishes to get a referral to a neurologist to see if a screw is potentially hitting a nerve.The patient is not interested in a revision surgery unless it would bring pain relief.No additional patient consequences have been reported.
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It was reported the patient has experienced multiple issues following implantation of bilateral temporomandibular joint implants three (3) years ago.Immediately following implantation, the patient developed bell¿s palsy on the right side and was informed by the surgeon that it was a possible reaction to the surgery.The patient has used a bite splint for three (3) years to align the bite.The patient had a root canal a couple months ago and the endodontist took cone beam imaging.Based on the imaging, the endodontist believes the device is rubbing the bone and that the splint increases the pain.The patient has an unspecified one (1) inch deformity in the jaw.The patient underwent a dry needling treatment one (1) year ago that did not provide adequate pain relief.The patient wishes to get a referral to a neurologist to see if a screw is potentially hitting a nerve.The patient is currently receiving botox shots in the jaw from their dentist in order to try to relax the muscles.The patient is not interested in a revision surgery unless it would bring pain relief.The patient has been told by an oral surgeon that the patient has experienced too much bone loss to undergo additional surgery.The patient will continue with maintenance from their pain management doctors and also experiment with hypnosis.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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