An event regarding malposition involving a triathlon femoral component was reported.The event was confirmed.Method and results: device evaluation and results: not performed as product remains implanted medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant indicated: excessive posterior tibial baseplate slope of 9°, relative varus position of the baseplate of 5°, excessive distal femoral bone resection with thin tibial bearing, twisting trauma as trigger event for clinical symptoms.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: clinician review of the records provided indicated: complex and multiple component malposition as related to baseplate malposition in varus and excessive posterior slope, varus deformity across the knee and excessive distal femoral bone resection with use of a thin cr bearing has contributed to progressive knee instability where a twisting trauma to the knee was the trigger event to bring clinical symptoms to the level of medical attention with revision surgery and liner exchange performed within 2-years of implantation.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Implanted.
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