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, a follow-up medwatch will be filed as appropriate.
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Pinnacle claim letter and medical records received.Claim letter alleges metallosis and elevated chromium level.After review of medical records, the patient was revised to address metallosis.Pre-operative assessment notes instability.Operative notes indicate that the patient previously had a fall and then sustained a periprosthetic hip fracture.Location of the fracture was not indicated.There was significant metallosis throughout the joint.There was an acetabular cyst that was lysed and evacuated of fluid.Doi: 2002, dor: (b)(6) 2017, (right hip).
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