(b)(4).Concomitant medical products: 15-105044, m2a tpr hi carbon 41/32mm lnr, 912570.X11-180312, bi-metric/x por nc lat 12x140, 774930.11-163688, 32mm m2a hi carbon hd std nk, 767120.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04296, 0001825034 - 2018 - 04298.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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It was reported that the patient underwent revision surgery approximately 9 years post initial surgery due to pain, limited range of motion, metallosis, pseudotumor and bone erosion.During the surgery it was found that anterior capsule had significant metallosis reaction and staining in the tissue.Radical resection removing the entire anterior and as much of the inferior and superior capsule.There was significant metallosis reaction around the acetabular implant with significant softening and bone loss.
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