Reported event: an event regarding malposition involving a triathlon baseplate was reported.The event was confirmed via medical review.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device remains implanted.Clinician review: -clinician review: a review of the provided medical records by a clinical consultant indicated: "the additional radiographs confirm that the femoral implant is at the very least hyper flexed, out of the range of acceptability.It may well be oversized as well which can only be determined using digital or acetate templates.The tibial implant is also hyper flexed with some posterior overhang.In my opinion, coupling the hyper flexion of the femoral component with an unresurfaced patella, that certainly can cause impingement with pain and stiffness that can result in the need for revision surgery, possibly of all components with most likely resurfacing of the patella.I would consider this an iatrogenic situation." -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: patient reported left knee pain and noted product is "too large".A review of the provided medical records by a clinical consultant indicated: "the additional radiographs confirm that the femoral implant is at the very least hyper flexed, out of the range of acceptability.It may well be oversized as well which can only be determined using digital or acetate templates.The tibial implant is also hyper flexed with some posterior overhang.In my opinion, coupling the hyper flexion of the femoral component with an unresurfaced patella, that certainly can cause impingement with pain and stiffness that can result in the need for revision surgery, possibly of all components with most likely resurfacing of the patella.I would consider this an iatrogenic situation." no further investigation for this event is possible at this time.If devices and/or additional information become available after revision surgery to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
|