(b)(4).Initial reporter occupation: lawyer.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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Revision of the right hip implant after pain and difficulty in walking.During the revision it was detected abundant reaction tissue with joint effusion blood serum from suspected serum / pseudotumor reaction.The histological examination showed an intense inflammatory reaction from a foreign body to a predominant macrophage component of the bone and periosteal soft tissues, conditioning aseptic osteolysis.Doi: (b)(6) 2007.Dor: (b)(6) 2019; right hip.Addition information received revealing that the prosthesis implanted in the patient has released metal particles in the implant site.It also stated that,necrotic tissue reactive from wear of the prosthetic components were sent for histological examination.
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