(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a4, b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.Visual examination of the provided pictures identified wear and discoloration on the spherical bearing face, there appears to be burrs (displaced material) on the bottom flat bearing surface but this is unclear as there are no photographs of the bottom bearing surface.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.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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Product has returned.Visual examination of the returned product identified scuffs and indentations / pitting to the articulation surface and other scuffs and indentations to other surfaces.This is evident in particular to the bottom flat bearing surface which exhibits what appears to be gouging of the material resulting in burrs.It is not clear on how these indentations, scuffs and gouges may have been caused with the information provided however it may indicate the presence of a third body or may have been caused by the instruments when being removed.Additionally, there are possible indications of mal tracking as the lot number is not fully readable which could indicate tracking against the lateral wall of the tray.With the available information, a definitive root cause cannot be determined.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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