First stage knee revision the surgeon (b)(6) 2018.Primary (b)(6) 2017.1st stage revision (b)(6) 2018: seven months post primary surgery, patient developed heat and swelling in right knee.Knee aspirated (b)(6) 2018.Nil bacterial growth noted.Patient had reports of "continuous aching" in right knee.Nil signs of implant subsidence, or loosening.First stage revision with antibiotic spacer.Nil further details known.Male patient (b)(6).
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Product complaint: 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.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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