MAUDE Adverse Event Report: ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE CROSS-LINKED HYALURONATE KNEE INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fall (1848); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Hot Flashes/Flushes (2153); Chills (2191); Dizziness (2194); Discomfort (2330); Numbness (2415); Diaphoresis (2452); Pallor (2468); Low Oxygen Saturation (2477); Balance Problems (4401); Paresthesia (4421); Unspecified Respiratory Problem (4464); Decreased Appetite (4569)

Event Date 04/26/2022

Event Type  Injury  

Event Description

My husband experienced a severe reaction to the gel-one knee injection within an hour and half of receiving the second gel-one injection-(first one given approximately one year before) on (b)(6) 2022.On (b)(6) 2022: severe symptoms began shortly after receiving gel-one knee injection to left knee.On (b)(6) 2022 with noted knee discomfort followed by several severe episodes of uncontrolled physical spinning with collapse, unable to move or get up with strong pulling sensation to his left side, profuse sweating alternate w chills, high bp and weakness until 911 was called: patient was admitted and finally discharged on (b)(6) 2022 despite continued high blood pressure as no findings in ordered testing.On (b)(6) 2022: symptoms of concern remained with knee pain, dizziness, light sensitivity, difficulty w focus/vision, fatigue, frequent bouts of high bp up to 201/125 or similar between meds, forgetfulness, often feeling cold on (b)(6) 2022 incident: sudden facial flushing, eyes red, metallic taste in mouth with numbness, feeling of throat closing, tingling sensation of hands-treated with liquid benadryl; on (b)(6) 2022: symptoms continue with fluctuating low blood pressure with readings 80/50 range follow by low normal range; temperature regulation issue-difficulty overheating alternating feeling cold, light sensitivity/vision problems, easily fatigue, little appetite, forgetfulness; frequent paleness in face and hands; on (b)(6) 2022- present: symptoms of blood pressure regulation with dangerous levels of fluctuations and temperature regulation, often with low oxygen levels continue to be ongoing as well as still debilitating fatigue, knee pain, and intermittent allergic reaction symptoms.Note: patient attended all neurological testing in which no findings, rheumatologist discharged patient after knee continued to worsen and referred to orthopedic surgeon which scheduled full knee replacement: patient has not been able to work since the event or do normal life activities; he has also been seen by pcp multiple times however no medications have helped with the concerning symptoms.Fda safety report id# (b)(4).

• Brand Name: GEL-ONE CROSS-LINKED HYALURONATE KNEE INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 15632976
• MDR Text Key: 302093694
• Report Number: MW5112729
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2022
• Patient Sequence Number: 1
• Treatment: CRESTOR; DAILY VITAMIN; LISINOPRIL; PROPANOL; TREXIMET
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening; Disability
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White