Zimmer biomet complaint (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.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.No product was returned, as it was reported the implant was modified to complete the procedure.No x-rays, scans, pictures, or physician's reports were provided.The design vendor and manufacturer of this device was notified of the fit issue and performed an investigation and provided their results.The design vendor found that the implant met all product requirements of a standard fit + 0.75mm implant, as requested on the design input form.The design vendor found that the thickness in certain portions of the temporalis region was greater than 6mm.It was stated that the thickness of this region could have been reduced more to accommodate preferences, but the implant was manufactured appropriately per the instructions.The dhr was reviewed, no non-conformances were found.There are no indications of manufacturing defects.For patient matched htr-pmi implants (pmxxxxxx) in the previous year (from the notification date) regarding fit issues with the implant, the calculated complaint rate is 1.07% which is no greater than the occurrence listed in the application fmea.The root cause of this complaint was determined to be outside the scope of the design/manufacturing process.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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