Review of the device history records indicate ten packs were manufactured and accepted into final stock with no reported discrepancies.There has been one other event for the lot referenced.Pi 1341607 has two packs of the same cement that were used during the same surgery.A review of the medical records by a clinician indicated: ¿on (b)(6) 2016 a revision of the left total knee femoral and tibial components was performed for a post-operative diagnosis of loose femoral component, partial loose tibial component, and intact patellar component.[¿] femur easily removed ¿ no significant attachment to femoral bone ¿ came off with cement still attached to metal.Tibia not well attached laterally but good attachment medially ¿ removed ¿ patella intact and retained.[¿] on (b)(6) 2015 an ap, lateral and oblique of the left knee demonstrates a cemented total knee arthroplasty with minimal cement visualized around the femoral and tibial components and with none visualized around the tibial keel or the femoral pegs.X-rays dated (b)(6) 2016 are ap and lateral of the left knee and leg length views show no gross migration of the knee, but the leg length indicates the knee is in approximately 5° of varus with a radiolucency around the tibial keel and anterior femoral component." the clinician concluded, "inadequate cement technique in this large, active man resulted in apparent loosening at the cement/bone interface.Since cement is not glue, adhesion is related to creating a large surface area at the bone interface to maintain fixation.No prosthesis related factors are shown to be involved in the post revision reported pain.There is no evidence that factors of faulty component or cement design, manufacturing or materials were responsible for this clinical situation." the investigation concluded that loosening was caused by inadequate cement technique.There is no evidence that factors of faulty component or cement design, manufacturing or materials were responsible for this clinical situation.If devices and/or additional information become available, this investigation will be reopened.Not available.
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