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: 0001032347-2020-00207, 0001032347-2020-00208, 0001032347-2020-00210, 0001032347-2020-00211, 0001032347-2020-00212.Medical products: tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 535280a.Tmj system left standard mandibular component 45mm / 7 hole, part# 24-6546, lot# 567720a.Tmj system right fossa component, small, part# 24-6562, lot# 503450a.Tmj system left fossa component, small, part# 24-6563, lot# 501530a.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.Occupation: patient.
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This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The non-conformance database was reviewed and there were no non-conformances were found.There are no indications of manufacturing defects.There have been 3 complaints for this item# 24-6562, lot# 503450a.The other 2 are the previous reports from this patient.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain leading to a revision, there is a complaint rate of 0.47%, which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding limited range of motion leading to a revision, there is a complaint rate of 0.21%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint could not 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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