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: 0001032347-2020-00625.Concomitant medical products: medical products tmj system right narrow mandibular component 55 mm, part# 01-6555, lot# 747640, tmj system right investigative fossa, large, part# 01-6564, lot# 109331, unknown screws, part# ni, lot# ni.
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It was reported that the patient will undergo a revision of temporomandibular joint implants on the right side nineteen (19) years following implantation due to a failing screw, periodic pain and swelling.X-rays revealed a radiolucency around the screw that the surgeon interprets as screw failure due to poor bone purchase.The surgeon wishes to replace the implant with a custom device because the patient has a thin arch, but no revision date has been reported at this time.No additional patient consequences have been reported.
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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.Operative notes were not provided.Xrays were provided and reviewed by a healthcare professional.Three views of the right mental on ct demonstrate a plate fixation device of the mandible.There are screws seen within the skull base with possible radiolucency surrounding a screw seen within the temporal bone on the coronal image laterally.Overall fit and alignment of the implants is appropriate.Arch thickness is not well evaluated on these three images.Upon reassessment of the reported event, it was determined to be not reportable.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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