It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, eighteen days post-implantation, the patient presented with swelling and a hematoma, a baker's cyst, and pain.The patient was prescribed medication to alleviate symptoms.Due diligence is in progress for this event; to date no further information has been provided and the final patient outcome is unknown.
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(b)(4).Concomitant medical products: medical product: vanguard cr ilok fem-rt 65: catalog#183008, lot#j7184508; polished finned tib tray 71mm: catalog#141253, lot#2022020964.Foreign: germany.Multiple mdr reports have been filed for this event.Please see associated report: 0001825034-2022-02155.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h6; h10.Visual and dimensional evaluations of the product could not be performed as the product remains implanted.Device history record review will not be performed as the reported event was determined to be unrelated to the implanted zimmer biomet device.Investigation results concluded that the reported event was due to non-device related factors.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Popliteal cyst (baker's cyst) is a common complication post knee replacement but can also be caused by other problems such as arthritis.Popliteal cysts are formed from excessive synovial fluid produced postoperative that causes the fluid to collect in a lump at the back of the knee.This varies in size and can cause pressure at the back of the knee, pain with bending or extending the joint, tightness and limited rom.Medical intervention of draining the cyst, therapy, medication, or any combination can be used to resolve the cyst.The complaint indicated the patient developed a post-operative complication of popliteal cyst, requiring medical treatment.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated or need additional medication in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : see h10 narrative.
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