GenVisc® 850 sodium hyaluronate 50653-0006-01Recalls & reported problems
Avanos Medical, Inc. · GenVisc® 850 sodium hyaluronate (P140005) is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. GenVisc 850 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. GenVisc 850 is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution). · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850653006016), received between Jan 5, 2017 and Jun 15, 2022 — classified as 12 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- No Apparent Adverse Event6
Patient problems
- Arthralgia7
- Pain5
- Bacterial Infection4
- Joint Swelling4
- Unspecified Infection2
- Inflammation1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) 2022 THE CLINIC REPORTED THE ADVERSE EVENT TO ORTHOGENRX WHO REPORTED IT TO THE GENVISC850 CALL CENTER THAT A FEMALE PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR TREATMENT AFTER RECEIVING A GENVISC 850 BILATERAL KNEE INJECTIONS ON (B)(6) 2022. THE PATIENT'S MEDICAL HISTORY INCLUDES OSTEOARTHRITIS WITH 3 ROUNDS OF GENVISC850 OVER MANY PREVIOUS YEARS WITH IMPROVEMENT IN MOBILITY/PAIN. THE PATIENT RECEIVED THE 1ST BILATERAL GENVISC850 INTRAARTICULAR KNEE INJECTION ON (B)(6) 2022 FOR THIS ROUND OF INJECTIONS. LIDOCAINE WAS ADMINISTERED FOR COMFORT AND OMNIPAQUE FOR THE FLUOROSCOPY FOR THE CORRECT PLACEMENT OF THE INJECTIONS. ON (B)(6) 2022 THE PATIENT WENT TO THE HOSPITAL WITH INCREASED PAIN RADIATING DOWN HER LEG. AT THE HOSPITAL THE PATIENT HAD A KNEE WASH-OUT PROCEDURE AND WAS STARTED ON IV ANTIBIOTICS. A CULTURE WAS DONE INDICATING THE PRESENT OF A STAPH INFECTION. THE ANTIBIOTICS WERE CHANGED (B)(6) 2022 TO VANCOMYCIN AND A CEPHALOSPORIN ANTIBIOTIC. THE CLINIC CONTACT INDICATED THE PATIENT IS DOING FINE. THIS CASE IS SERIOUS AND THE GENVISC850 OR THE ADMINISTRATION PROCEDURE INCLUDING THE LIDOCAINE AND OMNIPAQUE CANNOT BE EXCLUDED. (B)(6) 2022 FROM ORTHOGENRX: LOT R-1 FINISH
Patient problems: Bacterial Infection
MAUDE report 14697117 ↗InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem
(B)(6) 2022 THE CLINIC REPORTED THE ADVERSE EVENT TO ORTHOGENRX WHO REPORTED IT TO THE GENVISC850 CALL CENTER THAT A FEMALE PATIENT WAS HOSPITALIZED ON (B)(6) 2022 FOR TREATMENT AFTER RECEIVING A GENVISC 850 BILATERAL KNEE INJECTIONS ON (B)(6) 2022. THE PATIENT'S MEDICAL HISTORY INCLUDES OSTEOARTHRITIS WITH 3 ROUNDS OF GENVISC850 OVER MANY PREVIOUS YEARS WITH IMPROVEMENT IN MOBILITY/PAIN. THE PATIENT RECEIVED THE 1ST BILATERAL GENVISC850 INTRAARTICULAR KNEE INJECTION ON (B)(6) 2022 FOR THIS ROUND OF INJECTIONS. LIDOCAINE WAS ADMINISTERED FOR COMFORT AND OMNIPAQUE FOR THE FLUOROSCOPY FOR THE CORRECT PLACEMENT OF THE INJECTIONS. ON (B)(6) 2022 THE PATIENT WENT TO THE HOSPITAL WITH INCREASED PAIN RADIATING DOWN HER LEG. AT THE HOSPITAL THE PATIENT HAD A KNEE WASH-OUT PROCEDURE AND WAS STARTED ON IV ANTIBIOTICS. A CULTURE WAS DONE INDICATING THE PRESENT OF A STAPH INFECTION. THE ANTIBIOTICS WERE CHANGED (B)(6) 2022 TO VANCOMYCIN AND A CEPHALOSPORIN ANTIBIOTIC. THE CLINIC CONTACT INDICATED THE PATIENT IS DOING FINE. THIS CASE IS SERIOUS AND THE GENVISC850 OR THE ADMINISTRATION PROCEDURE INCLUDING THE LIDOCAINE AND OMNIPAQUE CANNOT BE EXCLUDED. AP (B)(6) 2022 FROM ORTHOGENRX: LOT R-1 FIN
Patient problems: Bacterial Infection
MAUDE report 14697018 ↗InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE GENVISC 850 CALL CENTER WAS NOTIFIED BY AN ORTHOGENRX EMPLOYEE THAT AN HCP REPORTED A MALE PATIENT WAS ADMITTED TO A HOSPITAL AND DIAGNOSED WITH A RIGHT KNEE INTRA-ARTICULAR JOINT INFECTION. THE AE ASSESSOR SPOKE WITH THE HCP (WHO GAVE THE INJECTION) FOR THE INVESTIGATION OF THE COMPLAINT OF THE RIGHT KNEE INTRA-ARTICULAR JOINT INFECTION ON (B)(6) 2022 AFTER A THIRD RIGHT KNEE INTRA-ARTICULAR GENVISC 850 INJECTION ON (B)(6) 2022 THE PATIENT'S MEDICAL HISTORY INCLUDES OSTEOARTHRITIS, DIABETES, GOUT, COPD, CHRONIC LOW BACK PAIN, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, BLADDER CANCER WITH PREVIOUS INJECTIONS OF GENVISC 850 WITH NO COMPLAINTS. THE PATIENT RECEIVED RIGHT KNEE INTRA-ARTICULAR GENVISC 850 INJECTIONS WITH THE FIRST ON (B)(6) 2022 , SECOND ON (B)(6) 2022 AND THIRD ON (B)(6) 2022 . THE HCP'S MEDICAL ASSISTANT DID THE PREPARATION WHICH INCLUDED PREPARING THE PATIENT'S KNEE AND THE SYRINGES THAT HELD THE LIDOCAINE, OMNIPAQUE AND GENVISC850. THE HCP COULD NOT PROVIDE DETAILS OF HOW THE MA PREPARED. THE HCP PROVIDED THE INJECTIONS. THE PATIENT RECEIVED THE LEFT KNEE INTRA-ARTICULAR GENVISC 850 INJECTIONS WITH THE FIRST ON (B)(6) 2022 , SECOND ON (B)(6) 2022 AND THIRD O
Patient problems: Bacterial Infection
MAUDE report 14597390 ↗InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem
THE GENVISC 850 CALL CENTER WAS NOTIFIED BY AN (B)(6) EMPLOYEE THAT AN HCP REPORTED A MALE PATIENT WAS ADMITTED TO A HOSPITAL AND DIAGNOSED WITH A RIGHT KNEE INTRA-ARTICULAR JOINT INFECTION. THE AE ASSESSOR SPOKE WITH THE HCP (WHO GAVE THE INJECTION) FOR THE INVESTIGATION OF THE COMPLAINT OF THE RIGHT KNEE INTRA-ARTICULAR JOINT INFECTION ON (B)(6) 2022 AFTER A THIRD RIGHT KNEE INTRA-ARTICULAR GENVISC 850 INJECTION ON (B)(6) 2022. THE PATIENT'S MEDICAL HISTORY INCLUDES OSTEOARTHRITIS, DIABETES, GOUT, COPD, CHRONIC LOW BACK PAIN, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, BLADDER CANCER WITH PREVIOUS INJECTIONS OF GENVISC 850 WITH NO COMPLAINTS. THE PATIENT RECEIVED RIGHT KNEE INTRA-ARTICULAR GENVISC 850 INJECTIONS WITH THE FIRST ON (B)(6) 2022, SECOND ON (B)(6) 2022 AND THIRD ON (B)(6) 2022. THE HCP'S MEDICAL ASSISTANT DID THE PREPARATION WHICH INCLUDED PREPARING THE PATIENT'S KNEE AND THE SYRINGES THAT HELD THE LIDOCAINE, OMNIPAQUE AND GENVISC850. THE HCP COULD NOT PROVIDE DETAILS OF HOW THE MA PREPARED. THE HCP PROVIDED THE INJECTIONS. THE PATIENT RECEIVED THE LEFT KNEE INTRA-ARTICULAR GENVISC 850 INJECTIONS WITH THE FIRST ON (B)(6) 2022, SECOND ON (B)(6) 2022 AND THIRD ON (B)(
Patient problems: Bacterial Infection
MAUDE report 14323108 ↗InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE HEALTH CARE PROVIDER (HCP) REPORTED TO AE ASSESSOR THAT AFTER THE 4TH BILATERAL KNEE INJECTION ON (B)(6) 2019 THE PATIENT WAS HOSPITALIZED FOR BILATERAL SEPTIC KNEE JOINTS. THE MEDICAL HISTORY OF THE PATIENT INCLUDES OSTEOARTHRITIS, BARIATRIC SURGERY, BACK PROBLEMS REQUIRING OCCASIONAL USE OF A CANE AND HYPERTENSION MANAGED WITH LISINOPRIL. ON (B)(6) 2019 THE PATIENT STARTED THE WEEKLY GENVISC 850 BILATERAL KNEE INJECTION SERIES WHICH WERE IMPROVING THE KNEE DISCOMFORT. ON (B)(6) 2019 THE PATIENT RECEIVED THE 4TH BILATERAL KNEE INJECTION. ON (B)(6) 2019 THE PATIENT WAS NOT GETTING PAIN RELIEF IN HIS LEFT KNEE SO HE WENT TO THE ORTHOPEDIC URGENT CARE AND X-RAYS WERE PERFORMED, GOUT WAS DIAGNOSED AND PREDNISONE WAS PRESCRIBED. ON (B)(6) 2019 THE PATIENT WENT TO THE EMERGENCY ROOM FOR DISCOMFORT IN HIS KNEES BILATERAL. THE ER WAS GOING TO SEND THE PATIENT HOME WHEN THE PATIENT INSISTED SOMETHING WAS WRONG. THEY TAPPED THE PATIENTS KNEES WITH RESULTS OF WBCS >70,000 IN THE LEFT KNEE AND >40,000 IN THE RIGHT KNEE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON 10/23/19, SENT TO SURGERY AND HIS KNEE JOINTS WERE WASHED OUT. A PICC LINE WAS INSERTED AND A SIX WEEK COURSE OF ANTIBIOTICS WA
Patient problems: Arthralgia; Unspecified Infection
MAUDE report 9354453 ↗InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE HEALTH CARE PROVIDER (HCP) REPORTED TO AE ASSESSOR THAT AFTER THE 4TH BILATERAL KNEE INJECTION ON (B)(6) 2019 THE PATIENT WAS HOSPITALIZED FOR BILATERAL SEPTIC KNEE JOINTS. THE MEDICAL HISTORY OF THE PATIENT INCLUDES OSTEOARTHRITIS, BARIATRIC SURGERY, BACK PROBLEMS REQUIRING OCCASIONAL USE OF A CANE AND HYPERTENSION MANAGED WITH LISINOPRIL. ON (B)(6) 2019 THE PATIENT STARTED THE WEEKLY GENVISC850 BILATERAL KNEE INJECTION SERIES WHICH WERE IMPROVING THE KNEE DISCOMFORT. ON (B)(6) 2019 THE PATIENT RECEIVED THE 4TH BILATERAL KNEE INJECTION. ON (B)(6) 2019 THE PATIENT WAS NOT GETTING PAIN RELIEF IN HIS LEFT KNEE SO HE WENT TO THE ORTHOPEDIC URGENT CARE AND X-RAYS WERE PERFORMED, GOUT WAS DIAGNOSED AND PREDNISONE WAS PRESCRIBED. ON (B)(6) 2019 THE PATIENT WENT TO THE EMERGENCY ROOM FOR DISCOMFORT IN HIS KNEES BILATERAL. THE ER WAS GOING TO SEND THE PATIENT HOME WHEN THE PATIENT INSISTED SOMETHING WAS WRONG. THEY TAPPED THE PATIENTS KNEES WITH RESULTS OF WBCS >70,000 IN THE LEFT KNEE AND >40,000 IN THE RIGHT KNEE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019, SENT TO SURGERY AND HIS KNEE JOINTS WERE WASHED OUT. A PICC LINE WAS INSERTED AND A SIX WEEK COURSE OF ANTIBIOTICS
Patient problems: Arthralgia; Unspecified Infection
MAUDE report 9354450 ↗InjuryJul 25, 2017No Apparent Adverse Event; No Apparent Adverse Event
PATIENT REPORTED TO ORTHOGENRX GENVISC 850 CALL CENTER THE FIRST 3 INJECTIONS OF GENVISC 850 WENT WELL. AFTER THE 4TH INJECTION OF GENVISC 850 HIS KNEE FELT WORSE AND HE HAD FLUID DRAINED. WHEN HE WALKS THE KNEE HURTS. THE BONE FEELS BROKEN INSIDE. WHEN BENDING THE KNEE A SOUND LIKE "KE KE KE" OCCURS, LIKELY CREPITUS. THIS AE ASSESSOR HAS PLACED MULTIPLE CALLS TO THE PT. AND THE PT. HAS NOT ANSWERED NOR RETURNED THE CALLS. IT IS NOT POSSIBLE TO ASSESS CONTRIBUTORY FACTORS WITHOUT THE PTS. MEDICAL HISTORY, PAIN LEVEL AND DIAGNOSTICS IF ANY WERE PERFORMED. THE GENVISC 850 CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. IF THE PT. RETURNS THE CALLS, THE CASE WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED UPON THE INFORMATION PROVIDED NO REMEDIAL ACTION IS REQUIRED. THIS CASE IS BEING CLOSED AS A SERIOUS BECAUSE THE PT. REPORTED AN EFFUSION WITH SIGNIFICANT PAIN AFTER THE 4TH GENVISC850 INJECTION. THE CASE IS LIMITED IN INVESTIGATION AND WILL BE CLOSED WITHOUT FURTHER FOLLOW-UP FROM THE AE ASSESSOR.
Patient problems: Arthralgia; Pain
MAUDE report 6742620 ↗InjuryJan 15, 2017No Apparent Adverse Event; No Apparent Adverse Event
PROVIDER CLINIC REPORTED TO ORTHOGENRX THAT THE PT. HAD SEVERE INFLAMMATORY REACTION TO A GENVISC 850 INJECTION. AE ASSESSOR HAS MADE MULTIPLE ATTEMPTS TO REACH PROVIDER TO ALLOW FOR FURTHER INVESTIGATION OF THIS REPORT. INVESTIGATION IS LIMITED DUE TO INABILITY TO SPEAK WITH THE PROVIDER. THE CASE WILL BE CLOSED AS SERIOUS GIVEN THE REPORT OF A SEVERE INFLAMMATORY REACTION AFTER THE GENVISC 850 INJECTION. THIS CASE WILL BE CLOSED WITHOUT FURTHER FOLLOW-UP FROM AE ASSESSOR. IF THE PROVIDER CONTACTS THE AE ASSESSOR BACK, THE CASE WILL BE REOPENED FOR FURTHER INVESTIGATION.
Patient problems: Inflammation
MAUDE report 6252880 ↗InjuryJan 7, 2017No Apparent Adverse Event; No Apparent Adverse Event
CLINIC REPORTED TO AE ASSESSOR THAT PT. HAD IMMEDIATE SWELLING OF KNEE WITH FIRST GENVISC 850 INJECTION IN THE KNEE. AE ASSESSOR SPOKE WITH THE CLINIC OPERATIONS SUPERVISOR FOR FURTHER INVESTIGATION OF THIS REPORT. PT. PRESENTED TO CLINIC ON (B)(6) 2016 WITH BILATERAL KNEE PAIN, RATED 6/10, WITH LEFT > RIGHT AND PAST MEDICAL HISTORY OF LEFT KNEE SURGERY IN 1965 FOR A FOOTBALL INJURY. CLINIC REPORTS EXISTING EVIDENCE OF SURGICAL SCARS AND WIRES AROUND THE LEFT PATELLA. BILATERAL GENVISC 850 INJECTIONS GIVEN ON (B)(6) 2016 FOR DIAGNOSIS OF KNEE PAIN AND BILATERAL SYNOVITIS. PT. RETURNED TO THE CLINIC ON (B)(6) 2016 AND THE RIGHT KNEE WAS SWOLLEN; NO REDNESS OR WARMTH NOTED. IT WAS NOT DOCUMENTED IN THE CHART THAT THE SWELLING RESULTED IMMEDIATELY AFTER THE GENVISC 850 INJECTION. RIGHT KNEE PAIN WAS RATED 1/10 AND 60 CC OF CLEAR YELLOW FLUID WAS ASPIRATED FROM THE RIGHT KNEE WITH A TORADOL INJECTION GIVEN INTO THE RIGHT KNEE. ON (B)(6) 2016 THE PT. RETURNED TO THE CLINIC FOR FOLLOW-UP AND A RIGHT KNEE ULTRASOUND SHOWED MODERATE EFFUSION; RIGHT KNEE ASPIRATE DONE WITH 25 CC OF CLEAR YELLOW FLUID ASPIRATED - NO PAIN INDICATED IN THE CHART. ON (B)(6) 2016 LEFT KNEE GENVISC 850 GIVEN FOR
Patient problems: Arthralgia; Joint Swelling; Pain
MAUDE report 6231869 ↗InjuryJan 7, 2017No Apparent Adverse Event; No Apparent Adverse Event
PROVIDER CLINIC REPORTED TO (B)(4) THAT THE PT. PAIN LEVEL INCREASED IN THE LEFT KNEE ON (B)(6)2016. AE ASSESSOR SPOKE WITH THE CLINIC FOR FURTHER INVESTIGATION OF THIS REPORT. PT. HAD BILATERAL KNEE INJECTIONS OF GENVISC 850 FOR OA DIAGNOSIS ON (B)(6) 2016. PT. CONTINUED WITH WEEKLY INJECTIONS ON ALTERNATING KNEES AND RECEIVED A TOTAL OF 2 INJECTIONS IN THE RIGHT KNEE AND 2 INJECTIONS IN THE LEFT KNEE PRIOR TO REPORTED INCREASED PAIN IN LEFT KNEE. ON (B)(6) 2016 ULTRASOUND INDICATES FLUID IN THE SUPRAPATELLAR SPACE - AN EFFUSION WITH 22 CC OF SEROUS FLUID REMOVED FROM THE LEFT KNEE AND A CORTISONE INJECTION WAS GIVEN IN THE LEFT KNEE. NO PT. PAIN RATING WAS PROVIDED BY THE CLINIC. CLINIC DID NOT NOTE OR HAVE ANY DIAGNOSTIC REPORT INDICATING INFECTION. THIRD GENVISC INJECTION IN LEFT KNEE WAS (B)(6) 2016; THIRD GENVISC INJECTION IN THE RIGHT KNEE WAS (B)(6) 2016. ON THE (B)(6) 2016 VISIT THE PT. PRESENTED TO THE CLINIC WITH INCREASED PAIN AND SWELLING IN LEFT KNEE. PAIN LEVEL WAS NOT RECORDED FOR THE LEFT KNEE. CLINIC STATES PT. HAD AN EFFUSION WITH 21 CC OF CLEAR YELLOW FLUID REMOVED BY ASPIRATION FROM THE LEFT KNEE; PT. WAS GIVEN A CORTISONE INJECTION IN LEFT KNEE. CLINIC DID NOT
Patient problems: Arthralgia; Joint Swelling; Pain
MAUDE report 6231836 ↗InjuryJan 6, 2017No Apparent Adverse Event; No Apparent Adverse Event
PROVIDER CLINIC REPORTED TO (B)(4) THAT A LEFT KNEE EFFUSION OCCURRED AFTER 2ND GENVISC 850 INJECTION GIVEN ON (B)(6) 2016. AE ASSESSOR SPOKE WITH CLINICAL OPERATIONS MANAGER FOR FURTHER INVESTIGATION OF THIS CASE. PT. VISITED CLINIC FOR CONSULTATION ON (B)(6) 2016 FOR COMPLAINT OF BILATERAL KNEE PAIN; PT. HAS A PAST MEDICAL HISTORY OF OA. PT. BEGAN BILATERAL KNEE INJECTIONS WITH GENVISC 850 ON (B)(6) 2016 WITH RATED PAIN 3-4/10 WITH INCREASED PAIN WHILE WALKING, STANDING AND SITTING FOR LONG PERIODS. SECOND INJECTION OF GENVISC 850 GIVEN IN RIGHT KNEE ON (B)(6) 2016 WITH RATED PAIN OF 4/10. SECOND INJECTION OF GENVISC 850 LEFT KNEE GIVEN (B)(6) 2016 WITH RATED PAIN OF 4/10. THIRD RIGHT KNEE INJECTION OF GENVISC 850 WAS GIVEN (B)(6) 2016 WITH RATED PAIN OF 3-4/10, HOWEVER, PT. COMPLAINED OF INCREASED PAIN IN LEFT KNEE RATED 10/10 WITH AN EFFUSION PRESENT; 28 CC OF CLEAR LIQUID ASPIRATED. KENALOG WAS GIVEN BY INJECTION INTO LEFT KNEE CAVITY. NO CLINIC NOTE ABOUT ULTRASOUND BEING PERFORMED. THIRD INJECTION OF GENVISC 850 LEFT KNEE GIVEN (B)(6) 2016 WITH VERBAL INDICATION OF IMPROVEMENT IN FUNCTION AND RATED PAIN 2-3/10. FOURTH INJECTION OF GENVISC 850 INTO RIGHT KNEE WAS GIVEN (B)(6)
Patient problems: Arthralgia; Joint Swelling; Pain
MAUDE report 6231318 ↗InjuryJan 5, 2017No Apparent Adverse Event; No Apparent Adverse Event
PROVIDER CLINIC REPORTED TO ORTHOGENRX THAT AFTER THE 5TH GENVISC 850 INJECTION IN THE RIGHT KNEE, PT. HAD INTENSE PAIN AND SWELLING IN RIGHT KNEE ALONG WITH RIGHT LOWER LEG SWELLING. AE ASSESSOR SPOKE WITH THE CLINIC FOR FURTHER INVESTIGATION OF THIS REPORT. PT. HAS A HISTORY OF MULTIPLE SERIES OF HYALGAN INJECTIONS FOR OSTEOARTHRITIS (OA). PT. WAS STARTED ON BILATERAL GENVISC 850 INJECTIONS ON (B)(6) 2016 FOR PAIN RATED 7 TO 8 OUT OF 10, EXACERBATED WITH ANY ACTIVITY; LEFT KNEE PAIN > THE RIGHT KNEE PAIN. PT. WAS ALSO ON CELEBREX FOR KNEE PAIN. GENVISC 850 INJECTIONS ENDED (B)(6) 2016. CLINIC STATES THAT PT. PRESENTED TO THE CLINIC ON (B)(6) 2016 FOR "EXTREME PAIN" WITH "SWELLING IN JOINT AND DISTAL JOINT LINE TENDERNESS". ULTRASOUND WAS PERFORMED ON (B)(6) 2016 AND SHOWED A "LARGE BAKER'S CYST WITH POSSIBLE VASCULAR COMPRESSION CAUSING SWELLING"; PT. WAS ALSO SENT TO THE EMERGENCY ROOM TO RULE OUT A DVT. PT. HAS NOT RETURNED TO THE CLINIC FOR FOLLOW-UP AND FINAL REPORT REGARDING THE POSSIBLE DVT WAS NOT AVAILABLE. A BAKER'S CYST IS TYPICALLY CAUSED WHEN EXCESS JOINT FLUID IS PUSHED INTO ONE OF THE SMALL SACS OF TISSUE BEHIND THE KNEE. THE SAC CAN FILL WITH FLUID AND PROTRUDE OUT
Patient problems: Arthralgia; Joint Swelling; Pain
MAUDE report 6226830 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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