The literature article entitled, "host-specific factors affect the pathogenesis of adverse reaction to metal debris" written by lari lehtovirta, aleski reito, olli lainiala, jyrki parkkinen, harry hothi, johann henckel, alister hart, and antti eskelinen published by bmc musculoskeletal disorders published 2019 was reviewed.The article's purpose to assess whether the development of armd (adverse reaction to metal debris) is actually affected by host-specific intrinsic factors.Data was compiled from 29 patients with bilateral revision of depuy asr mom hips (58 hips).It is noted that 24 patients had depuy asr xl thas but the femoral stem is not identified.It is unknown if these patients had bilateral thas or if a combination of hra and tha was utilized for these patients.The article does not provide adequate information to determine accurate quantities.All revisions were for armd with some patients receiving revision to one side at the first revision and the contralateral hip revised at the 2nd revision verse bilateral revisions at the same revision.The intraoperative findings and subjective reports are captured as adverse events in this complaint.Depuy products: asr head, asr cup, asr xl head, asr xl sleeve (augment), asr xl cup adverse events: revision for armd attributed to mom bearing wear.Reports of pain.Aseptic cup loosening.Elevated metal ion levels.Pseudotumor.Sense of instability.Sounds from hip (clacking, squeaking).Soft tissue necrosis via histopathological analysis.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.H10 additional narrative: added: h5, h7, h9.
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