(b)(4).Medical products: natural tibia trabecular metal two-peg porous fixed bearing catalog # 42530007102 lot # 64702610.Articular surface medial congruent (mc) catalog # 42522100810 lot # 64463596.Persona all poly patella catalog # 42540000035 lot # 64834784.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Multiple mdr reports were filled for this event: 0001822565-2021-01794, 3007963827-2021-00140, 0002648920-2021-00176.According to tabers medical dictionary ¿ manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.With anesthesia is (mua).Per clinical orthopaedics and related research (how to treat the stiff total knee arthroplasty? a systematic review), mua is used to treat and resolve arthrofibrosis (scar tissue).In the event a mua is unsuccessful in breaking up the adhesions/scar tissue a arthroscopic lysis of adhesions can occur.This is where the surgeon will go in and release the adhesions/scar tissue.These procedures are performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia and/or arthroscopic lysis is related to limited range of motion and stiffness due to adhesions/scar tissue.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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It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient underwent an arthroscopic lysis of adhesions with manipulation due to flexion contracture.Attempt for further information has been made, but no further information has been provided.
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