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Reported event: an event regarding wear, osteolysis, subluxation and disassociation involving a duracon insert was reported.The event was confirmed via clinician review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: "[.] x-ray [.] dated (b)(6) 2014 [.] the femur is posteriorly subluxated on the lateral x-ray of the knee.[.] x-rays dated (b)(6) 2019 [.] more marked osteolysis of the proximal tibia and the medial femoral condyle are noted, and posterior subluxation of the femur and an anterior subluxation of the tibial insert from the tibial tray are noted.[.] no primary total knee arthroplasty operative report or list of components implanted, no examination of either the replaced primary tibial insert or the revised primary total knee components from the (b)(6) 2019 surgery, no surgical pathology description of the damaged implants or description of any cement fragments from either revision surgery, and no evidence of cement used in the primary total knee arthroplasty are available.No x-rays of the primary right total knee arthroplasty which was performed in 1997 until (b)(6) 2014 when the posterior subluxation of the femoral component which was noted are available.After seventeen years in situ in this large male patient whose ligamentous stability was not documented, wear and subluxation of the tibial insert was noted.Simply replacing the liner with a thicker component without addressing any underlying balance issues likely resulted in the same forces subluxating the insert and knee five years later.Examination of the explanted components, and imaging and follow-up examinations between the primary surgery in 1997 and 2014 would confirm this mechanism of inevitable fatigue failure and rule out factors associated with implant manufacturing or materials as having contributed to this clinical situation.Regarding the osteolysis noted in the (b)(6) 2019 x-rays, poly wear particles from excessive forces on an unbalanced total knee arthroplasty are more likely to be associated with periprosthetic osteolysis in an uncemented total knee arthroplasty." -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the entire knee was revised due to pain and ¿catastrophic failure of his components¿ with osteolysis due to poly wear was performed.Clinician review on the provided medical records indicated that more marked osteolysis of the proximal tibia and the medial femoral condyle are noted, and posterior subluxation of the femur and an anterior subluxation of the tibial insert from the tibial tray are noted.Clinician indicated that simply replacing the liner with a thicker component without addressing any underlying balance issues likely resulted in the same forces subluxating the insert and knee five years later.The event could be related to inevitable fatigue failure and poly wear particles from excessive forces on an unbalanced total knee arthroplasty.However, the exact cause of the event could not be determined because insufficient information was provided.Additional information including primary total knee arthroplasty operative report and/ or list of components implanted, examination of either the replaced primary tibial insert or the revised primary total knee components from the (b)(6) 2019 surgery, surgical pathology description of the damaged implants or description of any cement fragments from either revision surgery, and evidence of cement used in the primary total knee arthroplasty, x-rays of the primary right total knee arthroplasty which was performed in 1997 until (b)(6) 2014 when the posterior subluxation of the femoral component which was noted are needed to fully investigate the event.If device and/ or further information becomes available or the product is returned, this investigation will be re-opened. it was reported that the customer was inquiring if the reported device is subject to a recall.Based on the review, the reported device has not been involved in a recall.The following devices were also listed in this report: unknown_joint replacement_product - unknown femoral component - lot unknown.Unknown_joint replacement_product - unknown tibial baseplate - lot unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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