Pinnacle litigation and medical records received.Litigation alleges pain, discomfort, weakness, limited adl, stress, anxiety, depression, insomia and ckd stage 3.After review of medical records the patient was revised to address pain and osteolysis.Mri confirm presence of ostial lysis around femur but no loosening.Clinical visit reported tenderness over greater trochanter, discomfort, instability, stiffness, difficulty adl, metalic streak artifact obscure the tendons, some cortical hypertrophy at the tip of the stem but no loosening.Doi: (b)(6) 2007; dor: (b)(6) 2018; right hip.
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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