Zimmer biomet complaint: (b)(4).The device will not be returned to zimmer biomet for investigation because it remains implanted.The investigation is in process.Once the investigation is completed, a follow-up mdr report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00371, 0001032347-2019-00372, 0001032347-2019-00373, 0001032347-2019-00375, 0001032347-2019-00376, 0001032347-2019-00377.Concomitant medical products: tmj system right narrow mandibular component, cat# 01-6545, lot# 710730a; tmj system left narrow mandibular component, cat# 01-6546, lot# 541380d; tmj system right fossa component small, cat# 24-6562, lot# 721350a; tmj system left fossa component small, cat# 24-6563, lot# 721500a; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; tmj system cross drive fossa screw, cat# 99-6579, lot# unk.
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This follow-up report is being submitted to relay additional information.The complaint was opened because taylor billard, tmj tracking coordinator reports revision due to necrosis.Because a revision surgery occurred, the complaint is confirmed.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.It was reported that "the surgeon had to redo her right side due to necrosis and that it was the surgeon's fault and not our fault." there was no alleged malfunction of the devices.The non-conformance database was reviewed for the mandible and fossa components.Nc8172 was opened to evaluate the seals created by the atlas vac sealer, however, it was determined that the seals were of adequate strength and integrity.There are no indications of manufacturing defects.This was the only complaint for these lots for the mandible and fossa components.The most likely underlying cause could not be determined from the information provided.It is possible that there was a patient condition that led to the issue.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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