BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Pain (1994); Inadequate Pain Relief (2388)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet (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: 0001032347-2020-00352, 0001032347-2020-00353, 0001032347-2020-00354, 0001032347-2020-00355.Medical products: 2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni; tmj system cross drive emergency fossa screw 2.3mm x 7mm, part# 99-6587, lot# ni; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 694740; tmj system left fossa component, small, part# 24-6563, lot# 826700.Occupation ¿ patient.
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Event Description
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It was reported by the patient that they are experiencing various issues following implantation of temporomandibular joint implants on the left side approximately eleven (11) years ago.The implanting surgeon reports that there were no issues with the implants during follow-up appointments.The patient reports a gash on the inside of the right cheek.The patient has received nerve blocks that are inadequate in providing pain relief.The patient reports seeing a neurosurgeon for a neurostimulator implant to treat pain.No additional patient consequences have been reported.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed because additional measures were reported to have been taken to help the patient manage her pain.No product was returned as the devices remain implanted; 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 for the fossa component; no non-conformances were found.There are no indications of manufacturing defects.There have been 7 complaints of pain for this item# 24-6563, lot# 826700, 5 from this same patient and 2 from another patient.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain, there is a complaint rate of 4.04%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause 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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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This report is being submitted to update additional information in section b4, b5, g3, e1, e2, e3, g2, g6, h2, h6, h10.
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Event Description
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It is further reported that the patient is still in pain and now has an implanted neuro stimulator with the leads going to the trigeminal nerve and to the back of her head to alleviate severe headaches.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned as the devices remain implanted, therefore no functional tests or inspections could be performed.No medical records were provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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