(b)(4).Report source: (b)(6).Concomitant medical products: offset tib tray 2.5mm adaptor, catalog# 141490 lot# 207560, vanguard (tm) ssk femoral catalog # 183300 lot # 460060, agc modular post screw catalog # 153103 lot # 570770, rhk cemented stem catalog # 159405 lot unknown, biomet offset tibial tray 67mm catalog # 141482 lot # 985260 , vngd sskpsc tib brg s 16x63/67 catalog # 183826 lot # 467180 , series a pat std 31 3 peg catalog # 184764 lot 494690.Customer has indicated that the product will not be returned because it was discarded by hospital.The investigation is in process.Multiple mdr reports were filled for this event: 0001825034-2019-01022, 0001825034-2018-05848, 0001825034-2019-01017, 3002806535-2019-00359.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
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It has been reported by the hospital that a patient underwent an initial knee replacement surgery on an unknown date.Subsequently, a revision procedure was performed due to tibial component loosening.During the revision the surgeon experienced difficulties with extraction of distal tibial component and femoral component, which were left in situ.The products were removed during further revision.
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It has been reported by the hospital that a patient underwent an initial knee replacement surgery on an unknown date.Subsequently, a revision procedure was performed due to tibial component loosening.During the revision the surgeon experienced difficulties with extraction of distal tibial component and femoral component, which were left in situ.The products were removed during further revision.
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