Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Date of receipt of complaint : (b)(6) 2024.On (b)(6) 2020 patient underwent a first stage of lt tkr revision due to "infection and inflammatory reaction due to internal joint prosthesis (left)" during which her implants were removed and an antibiotic spacer was implanted.Thereafter patient was placed in plaster cast/brace and knee fixation and received a long term systemic antibiotic treatment under laboratory monitoring.After 6 weeks of antibiotic treatment with vancomycin and laboratory monitoring for additional 2 months, it was found that there was no inflammation of the infection following cessation of the antibiotics and the knee was "quiet", the second stage of the revision was carried out (b)(6) 2020 (noting it was after 9 prior infection revisions).On (b)(6) 2020 follow-up visit - crp levels reduced to 12 without antibiotics, imaging ¿ implant in good position with ranges of flex and bend as expected in her condition.Less than 2 years after implantation patient complained of heavy sensation on the lt leg and instability of left knee.Upon examination on (b)(6) 2023 - over flexion of 20 degrees and lack of stability ml.On imaging: impression of loosening of the two components.In the tibia observed migration of the implant and the stem tunnels it way through the lateral cortex.A radiolucent line around the femoral component in the metaphysical part.Puncture was taken.On (b)(6) 2023 follow up visit - infectious process overruled.It was decided to carry out a lt tkr revision on the background of suspected fracture of the liner and the axis system of the implant and suspected loosening of the components.On (b)(6) 2023 ((b)(4) captured for the 2nd revision): patient underwent a lt tkr revision.In a follow-up visit on (b)(6) 2023 ¿ post revision on the background of aseptic loosening and fracture of the implant.Good stability.
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