Litigation alleges pain, burning sensation, difficulty moving around, tingling and numbness, ringing ears, vision problems, bone loss and decreased mobility, metallosis, injury and disfigurement.Clinic visit notes alleges myalgia, neuropathy and low back pain.It was also alleged that lab results revealed elevated levels of cobalt and chromium in the blood; no values provided.
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(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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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