Allegedly, when the insert was removed during the tka revision operation, there were clear signs of lipid absorption and participation in the removed insert, causing delamination and pitting.Physician's findings: since this is an early phenomenon within 2 years after surgery, there are concerns about product problems and long-term clinical results.Additional information received on 01/22/2021: allegedly, the patient was revised due to loosening of both the femur and tibial components as well as infection.Additional information received on 01/24/2021: primary operation date is (b)(6) 2018.Additional information received on 01/27/2021: product id's and lot numbers for tibial and femur revised components were obtained.(b)(4).
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Allegedly, when the insert was removed during the tka revision operation, there were clear signs of lipid absorption and participation in the removed insert, causing delamination and pitting.Physician's findings: since this is an early phenomenon within 2 years after surgery, there are concerns about product problems and long-term clinical results.Additional information received on 01/22/2021: allegedly, the patient was revised due to loosening of both the femur and tibial components as well as infection.Additional information received on 01/24/2021: primary operation date is (b)(6) 2018.Additional information received on 01/27/2021: product id's and lot numbers for tibial and femur revised components were obtained.Additional information received on 04/29/2021: revision facility and surgeon confirmation.(b)(4).
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