Reported event: an event regarding incorrect selection involving a triathlon femoral component was reported.The event was confirmed by medical review.Method & results: -device evaluation and results: visual dimensional functional and material analysis could not be performed as the device was not returned.- clinician review: the available medical records were provided to the consulting clinician for a review which was rejected stating, " re pi - 2341468 which represents a male patient.Event description states: "size 6 triathlon beaded femoral press-fit.Cuts by mako for size 5.Not realized by surgeon.Post-op films.Clear space between anterior flange.Plan to revise femur and poly (b)(6) 2020." undated, unlabeled x-ray lateral left knee demonstrates an uncemented ps tka with a cemented patellar component and a 3 mm lucency behind the anterior flange of the patellar component.Implant labels dated 3/3/20: triathlon #6 left pf femur, #6 triathlon tritanium tibial component, #6/13 x3 ps tib.Insert, 38/11 x3 asymmetric patella.Implant labels dated 3/4/20: #5 ps left triathlon femur, #5/14 x3 ps tib.Insert.No clinical or pmh, no patient demographics, no examination of explanted components, no operative reports, no serial x-rays.The unlabeled x-ray appears to confirm the event description, but there is insufficient data to create a medical report on this case.-device history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: it was reported that the patient had a revision as a size 6 femur was implanted in place of size 5 femur.The available medical records were provided to the consulting clinician for a review which noted that undated, unlabeled x-ray lateral left knee demonstrates an uncemented ps tka with a cemented patellar component and a 3 mm lucency behind the anterior flange of the patellar component.Implant labels dated (b)(6) 2020 : triathlon #6 left pf femur, #6 triathlon tritanium tibial component, #6/13 x3 ps tib.Insert, 38/11 x3 asymmetric patella.Implant labels dated (b)(6) 2020 : #5 ps left triathlon femur, #5/14 x3 ps tib.Insert.No clinical or pmh, no patient demographics, no examination of explanted components, no operative reports, no serial x-rays.The unlabeled x-ray appears to confirm the event description, but there is insufficient data to create a medical report on this case.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
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