Pinnacle litigation record received.Litigation alleges injury, pain, discomfort, inflammation, limited range of motion, difficulty standing or walking, fatigue, necrosis and/or metallosis, lack of mobility, patient experienced dis-articulation and slipping feeling in the hip joint.Doi: unknown - 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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