Reported event: an event regarding subsidence involving a triathlon baseplate was reported.The event was confirmed via clinician review of the provided medical records.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 information by a clinical consultant indicated: "this 70-year-old patient underwent a primary cementless total knee arthroplasty and then slightly more than four months later required revision for subsidence of the tibial baseplate.I can confirm that patient had a primary total knee arthroplasty and that the tibial baseplate subsided into varus.I cannot completely confirm that a revision occurred although i did see usage sheets with revision implants.The root cause of this event cannot be determined with certainty.However failure due to subsidence within four months following the initial surgery speaks of a failure of initial fixation which could be multifactorial in cause, including surgical technique factors, patient compliance and activity level as well as bmi.It would be highly unlikely that the implant itself contributed to the failure.In most cases the failure of fixation is due to factors including tibial preparation, bone quality and insertion technique.Proper sizing and positioning also plays a role.With the information provided i would not assign any causality to the implant itself." product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's right knee was revised due to subsidence of the tibial baseplate.A review of the provided medical records by a clinical consultant indicated the following: "i can confirm that patient had a primary total knee arthroplasty and that the tibial baseplate subsided into varus.I cannot completely confirm that a revision occurred although i did see usage sheets with revision implants.The root cause of this event cannot be determined with certainty.However failure due to subsidence within four months following the initial surgery speaks of a failure of initial fixation which could be multifactorial in cause, including surgical technique factors, patient compliance and activity level as well as bmi.It would be highly unlikely that the implant itself contributed to the failure.In most cases the failure of fixation is due to factors including tibial preparation, bone quality and insertion technique.Proper sizing and positioning also plays a role.With the information provided i would not assign any causality to the implant itself." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
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