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: 0001032347-2021-00013, 0001032347-2021-00014, 0001032347-2021-00044, 0001032347-2021-00045, 0001032347-2021-00046, 0001032347-2021-00048, 0001032347-2021-00049, 0001032347-2021-00050, 0001032347-2021-00051, 0001032347-2021-00052, 0001032347-2021-00053, 0001032347-2021-00054, 0001032347-2021-00055.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot# 972390d.Tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 819000a.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.Unknown mandible screw, part# ni, lot# ni.Unknown mandible screw, part# ni, lot# ni.Unknown mandible screw, part# ni, lot# ni.Unknown mandible screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.
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It was reported the patient experienced limited opening, pain, discomfort, tightness, swelling and infection on the left side eight (8) months following implantation of bilateral temporomandibular joint implants.No cultures have been taken and no medications or additional treatment have been administered.The patient¿s current condition was described as improved but still experiences discomfort, tightness and swelling.No revision is planned at this time.No additional patient consequences have been reported.
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