(b)(4).Concomitant medical products: 00875505202 allofitâ®-s it alloclassicâ®, shell for acetabulum, uncemented, 52/ii lot number 3097158.00877501036 bioloxâ® delta ceramic taper liner, size ii / 36 i.D.For use with 52 mm o.D.Size ii shell lot number 3087512.00877503602 bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14 lot number 3095862.Report source: foreign: germany.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.A ct scan was provided but not sent for review as additional ct slices are needed for a complete picture of the reported issue.Other medical records and mri provided were for the knee.A definitive root cause cannot be determined.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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