Zimmer biomet complaint (b)(4).The device will not be returned for analysis; 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: 0001032347-2020-00542, 0001032347-2020-00544, 0001032347-2020-00545, 0001032347-2020-00546, 0001032347-2020-00547, 0001032347-2020-00548, 0001032347-2020-00549.Medical products: tmj system right standard mandibular component 55mm / 12 hole, part# 24-6555, lot# 873530b.Tmj system left standard mandibular component 55mm / 12 hole, part# 24-6556, lot# 836280b.Tmj system right fossa component, medium, part# 24-6560, lot# 861240b.Tmj system left fossa component, medium, part# 24-6561, lot# 838220a.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 2.7mm 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 emergency fossa screw 2.3mm x 9mm, part# 99-6589, lot# ni.Initial reporter: patient.
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It was reported that the patient has experienced multiple issues following implantation of bilateral temporomandibular joint prostheses one (1) year ago.One (1) month following implantation, the patient reports their ear drum ruptured and the implants on the left side are pushing into the eustachian tube and auditory canal.The patient has lost most of their hearing on the left side and says it is too painful to wear a hearing aid.The patient reports pressure on the left cheek and sinus.The implant on the right side squeaks.The patient reports that multiple ct scans have been taken, and they are seeing an ent/oral maxillofacial specialist and neurologist.No additional patient consequences have been reported.
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