Reviewed medical records received on 11 may 2018.Left knee revised to address pain, instability, medial tibial collapse, and aseptic loosening of the tibia base plate at the cement to implant interface.Revising surgeon identified a very villous synovitis, consistent with implant loosening.He indicated femur and patella components were well-fixed, but the tibia base plate was loose at the cement to implant interface.Tibia cement mantle was not loose with respect to tibia bone.Femur, tibia, and insert were revised; patella tracked well, with no baja, so it was retained.Doi: (b)(6) 2014; dor: (b)(6) 2017; (left knee).
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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