It was reported that this patient's previously revised knee was revised a second time due to pain and instability.The patient's attune revision knee components were removed and replaced by an s-rom noiles hinged femur, an lps hinged rp insert, and a sigma revision mbt tibial tray.Depuy smartset medium viscosity bone cement would have been used in the prior revision procedure, since the hospital only stocks smartset cement.The product codes and lot numbers for the cement is not available, since the cement used was hospital inventory ordered directly from depuy.Doi: (b)(6) 2020 dor: (b)(6) 2021 right 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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