Patient underwent a revision of a smith & nephew uni knee to and attune primary total knee replacement on the (b)(6) 2021.The same patient had his attune primary knee replacement revised to an attune revision knee replacement today; reasons for revision as stated by the surgeon were pain, inflammation, stiffness, varus positioning of tibial component and incorrect rotation of femoral component.Doi: (b)(6) 2021, dor: (b)(6) 2021, unknown knee.
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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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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