(b)(6).Concomitant products: item #unk, unknown head, lot #unk; item #unk, unknown cup, lot #unk; item #unk, unknown liner, lot #unk; item #unk, unknown stem, lot #unk.Huk, o.L., bansal, m., betts, f., rimnac, c.M., lieberman, j.R., huo, m.H., & salvati, e.A.(1994).Polyethylene and metal debris generated by non-articulating surfaces of modular acetabular components.The journal of bone and joint surgery, 76 b(4), 568-574.Retrieved from http://bjj.Boneandjoint.Org.Uk/content/jbjsbr/76-b/4/568.Full.Pdf.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 in a journal article study reported light microscopy showed eosinophilic, amorphous, acellular necrotic debris, with metal debris appearing as opaque black particles from the screw-cup junction.No further information is available.
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