It was reported a patient underwent a left total knee arthroplasty on (b)(4) 2016.Subsequently, the patient was revised on (b)(6) 2016 due to bone fracture caused by a fall, unrelated to the implants.The femoral component and the bearing were removed and replaced.During the revision procedure, the lug on the femoral component could not be removed in order to attach the stem housing.There was a delay of approximately 30 minutes.Another femoral component was used to complete the procedure.No further information has been provided.
|
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Review of device history and manufacturing records found no evidence of product non-conformance.Evidence of damage from the attempted removal using pliers, a lug wrench and a drill chuck is noted on the device and evaluation of the device indicates that the improper tools were used to remove the medial peg.Root cause of the event was most likely due to the customer using the wrong tools to try and remove the peg as the peg was removed during the evaluation with the correct instrument based on the surgical technique (peg wrench); however, a conclusive root cause could not be determined.There are warnings in the package insert that state that this type of event can occur: under warnings, it states, "the surgeon is to be thoroughly familiar with the surgical technique, implants and instruments prior to performing surgery.".
|