(b)(4).Foreign: (b)(6).Literature: huitema, g.C., de vries, l., verboom, t.W., spekenbrink-spooren, a., & steens, j.(2022).Patella related problems as common reason for revision of nexgen ps® total knee arthroplasty without patella resurfacing: an analysis of 5911 primary total knee arthroplasties registered in the (b)(6) register.The knee, 34, 217¿222.Https://doi.Org/10.1016/j.Knee.2021.12.008.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01463, 0001822565-2022-01465.
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A journal article was retrieved from the knee (2022) that reported a retrospective study from the (b)(6) that accumulated data from the dutch arthroplasty register (lroi).The purpose of the study was to investigate if there was a difference in revision rate and reason for revision within 8 years after single brand primary cemented tka with or without patella resurfacing, using data from the (b)(6) register.The study reported 50 patients were revised due to malalignment.Due diligence is complete as it was reported no further information is available.As no additional information or product has been received, we are unable to provide further information.
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