(b)(4) medical records ad (b)(6) 2022.Pdf were reviewed by clinician.On (b)(6) 2016, the patient had a left total knee arthroplasty.Depuy components, including depuy patella and depuy cement x2 were used during this procedure.On (b)(6) 2021, the patient had a revision all components to address failed left total knee replacement due to aseptic loosening of the tibial component.During the procedure the surgeon reported that the femoral component was well fixed, the tibial tray was grossly loose with intact cement mantle.The surgeon also observed some bone loss and cystic changes along the femur.There was polywear and synovial reaction noted.Competitor products were implanted during this procedure.Doi: (b)(6) 2016.Dor: (b)(6) 2021.Left 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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