¿voluntary report received (mw5113219) patient stated: i had arthritis and saw an orthopedic surgeon.He implanted an attune l knee prothesis.From day 1 i had problems.Severe pain; swelling and even the physical therapist relayed symptoms unusual.I finally had ct done and it showed debonding of prothesis and the original surgeon relayed he does not do revisions i finally found an excellent ortho doctor w/ (b)(6), and he saw results of ct and he replaced the attune device w/ a stryker device.But in interim of follow up from 1st surgery implant of attune device, i had additional surgery for left knee neuroma; then still had issues and swelling.Recently i had the peroneal nerve left knee decompressed by same surgeon who did the revision: dr.(b)(6).The original surgeon and his colleague he sent me to treat me as a hysterical female.Ps i am an rn in my 60's so i know my body very well, and i knew the severe pain i was feeling was not normal.Even dr.(b)(6), the original surgeon, his own therapist had admitted to met the pain and symptoms i was having were very abnormal.".
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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.Dmf# - 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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