An event regarding crack/fracture involving a triathlon insert was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis concluded: 'delamination, burnishing, scratching and third-body indentation were observed on the insert condyles.These are common damage modes of uhmwpe.Explantation damage and wear impression markings were also observed on the insert.No material or manufacturing defects were observed on the surfaces examined'.There is also evidence of posterior edge loading of the femoral component on to the tibial insert.Medical records received and evaluation: not performed as medical records were not provided.Device history review: indicates all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the material analysis report indicated that delamination, burnishing, scratching and third-body indentation were observed on the insert condyles.These are common damage modes of uhmwpe.Explantation damage and wear impression markings were also observed on the insert.No material or manufacturing defects were observed on the surfaces examined.There is also evidence of posterior edge loading of the femoral component on to the tibial insert which may have contributed to the fracture of the posterior aspect of the tibial insert.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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