(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2019-05362, 0001825034-2019-05366 concomitant medical products: vgxp intlk femoral rt 67.5 item# 195911 lot# 070690, vgxp xp e1 tib brg rl 10x71 item# 195780 lot# 476510, vgxp xp inlk pri tib tray 75mm item# 195757 lot# 111730, series a pat thn 34 3 peg item# 184786 lot# 524530.Unknown palacos cement report source: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up is being submitted to relay additional information.No devices were received; therefore, the condition of the components is unknown.Primary operative notes do not suggest any intra operative complications.Office notes from six week follow up to one year confirm patient had pain, stiffness and a decrease in flexion.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.Root cause cannot be determined.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.
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