Oct 17, 2017: medical records and implant photos received.Update dec 7, 2017: translated litigation and medical records received.Litigation alleges inflammation, elevated metal ions, unexplained fever, pain, ambulation difficulties, squeaking/grinding sound, metallosis and granuloma.After review of medical records for mdr reportability, it was reported that the patient was revised to address metallosis with progressive pain and very high values of cobalt at almost 40 x the normal amount.Revision notes reported small dark effusion, immense quantity of black tissue like carbon, cone of the stem is fully oxidized, metallosis, and granuloma.Medical reports indicate bursitis, hypersensitivity to metal, armd/altr, synovitis, effusion in the bursa of the psoas.Part and lot numbers are unknown.This complaint was updated on: december 07, 2017.
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