Summary report received for attune cementless posterior stabilized rotating platform knee.Tka were completed between august 1, 2019 to december 31, 2019.60 patients were involved in the final summary.Of those 60 patients, 53 had underwent a patella resurfacing.5 revisions identified: tibial revision due to loosening of the tibial component at the bone to implant interface.Tibial revision due to loosening of the tibial component at the bone to implant interface.Tibial and femoral component revision due to loosening at the bone to implant interface.Tibial and femoral component revision due to pain.Revision due to mechanical complication.Adverse events: post-hemorrhagic/anemia (21 patients), abnormal reaction/complication related to implant/surgery (8 patients), pain (6 patients), knee instability (2 patients), infection/inflammation (1 patient), osteonecrosis of tibia (1 patient), knee internal derangement (1 patient), abnormal gait (1 patient).
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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