Zimmer biomet complaint- (b)(4).Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.Kumar, v., pandit, h.G., liddle, a.D., borror, w., jenkins, c., mellon, s.J., murray, d.W.(2015).Comparison of outcomes after uka in patients with and without chondrocalcinosis: a matched cohort study.Knee surgery, sports traumatology, arthroscopy, 25(1), 319-324.Doi:10.1007/s00167-015-3578-8.
|
Information was received based on review of a journal article titled, "comparison of outcomes after uka in patients with and without chondrocalcinosis: a matched cohort study" which aimed to report the outcome of a consecutive series of patients with chondrocalcinosis and medial compartment osteoarthritis treated with uka matched to controls, using the oxford.This complaint addresses one revision due to avascular necrosis of lateral femoral condyle leading to secondary osteoarthritis at 9 months.There has been no further information provided and the patient outcome is unknown.
|