(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices used for treatment.Medical records were not provided.Ifu has been reviewed and stated that the gts implant stem are indicated for primary surgery.The root cause of the reported issue is attributed to use error.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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