Update to event details.Reported event: an event regarding loosening involving a triathlon patella was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of medical records with a clinical consultant indicated according to the product inquiry a patient who underwent a right total knee arthroplasty complained of "loosening" and wanted to know if the implants were subject to recall.The patient also underwent an aspiration.I can confirm that the patient underwent the right total knee arthroplasty since i was able to review the operation report.I have no other information about the aspiration and i cannot confirm this.Based upon the assumption that the implant could be "loose" the root cause of this event cannot be determined with certainty.Nor can loosening be determined with certainty without any workup including bone scans, ct scan, serial radiographs.The root cause of loosening of what would appear to be a cementless implant (the surgeon made no indication whether these implants were cemented or not) are multifactorial including surgical technique, alignment, position, and restoration of kinematics, bone preparation and proper implantation, if cemented, then cement technique, patient factors including activity level and bmi.With the information given i would not assign any causality to the implant itself." -product history review: review of the device history records indicate 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: a review of medical records with a clinical consultant indicated according to the product inquiry a patient who underwent a right total knee arthroplasty complained of "loosening" and wanted to know if the implants were subject to recall.The patient also underwent an aspiration.I can confirm that the patient underwent the right total knee arthroplasty since i was able to review the operation report.I have no other information about the aspiration and i cannot confirm this.Based upon the assumption that the implant could be "loose" the root cause of this event cannot be determined with certainty.Nor can loosening be determined with certainty without any workup including bone scans, ct scan, serial radiographs.The root cause of loosening of what would appear to be a cementless implant (the surgeon made no indication whether these implants were cemented or not) are multifactorial including surgical technique, alignment, position, and restoration of kinematics, bone preparation and proper implantation, if cemented, then cement technique, patient factors including activity level and bmi.With the information given i would not assign any causality to the implant itself." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The patient would like to know if his implants were part of a recall.A review indicated no recalls were associated with the implants.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.
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