Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Loss of Range of Motion (2032); Scar Tissue (2060)
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Event Date 06/22/2022 |
Event Type
Injury
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Event Description
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It was reported the patient underwent a left knee manipulation under anesthesia approximately forty days post-implantation due to arthrofibrosis, stiffness, and limited flexion.It was reportedly resolved the same day and all implants remain in place.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02759.Medical devices: femur trabecular metal cruciate retaining (cr) narrow porous catalog#: 42502206201 lot#: 65258501.Natural tibia trabecular metal two-peg porous fixed bearing left size d catalog#: 42530006701 lot#: 65261755.Nexgen complete knee solution, trabecular metal standard primary patella catalog#: 00587806532 lot#: 65208061.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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).This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia is related to limited range of motion and stiffness due to adhesions/scar tissue.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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