Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." patient is bilateral and it is unknown which component was revised therefore the following sections could not be completed due to the part/lot information could be: lot number - 439998, expiration date - jan 31, 2018, manufacture date ¿ jan 7, 2008.Or the part/lot information could be: lot number - 439984, expiration date - dec 31, 2017, manufacture date ¿ dec 24, 2007.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00348 / 00349).
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It was reported that the clinical patient underwent initial bilateral partial knee arthroplasties on (b)(6) 2008.Subsequently, the patient was revised on the left side to a total knee on (b)(6) 2012 due to tibial collapse, cystic defect, pain, and decreased function.Operative report noted well-fixed femoral component and loose tibial plate during the procedure.The patient was revised on the right side to a total knee on (b)(6) 2014 due to femoral loosening and acl deficiency.Operative report noted osteophytes and bone loss during the procedure.
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