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.Lewold, s., goodman, s., knutson, k., robertson, o., & lidgren, l.(1995).Oxford meniscal bearing knee versus the marmor knee in unicompartmental arthroplasty for arthrosis.The journal of arthroplasty, 10(6), 722-731.Doi:10.1016/s0883-5403(05)80066-x.
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Information was received based on review of a journal article entitled, "oxford meniscal bearing knee versus the marmor knee in unicompartmental arthroplasty for arthrosis.A swedish multicenter survival study".It was reported that fifteen (15) months after a revision for loosening, the patient underwent a second revision due to fractured prosthesis.At this time, all components were removed and replaced with a total knee system.
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