Zimmer biomet complaint (b)(4).Medical products: item # ni, lot #ni, unknown tmj system right fossa component; item # ni, lot # ni, unknown tmj system left mandible component; item # ni, lot # ni, unknown tmj system right fossa component.Foreign reporter: united kingdom.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The case was reviewed by 3d systems during the design process of a possible replacement patient matched tmj device.3ds provided images of the patient's anatomy from the surgeon as of april which confirmed the mandibular head is displaced and is not mating with the center of the fossa component.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00195; 0001032347-2022-00337; 0001032347-2022-00338.
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