Gel-One® Cross-linked Hyaluronate 00-1111-001-00 (UDI 04987541300911)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04987541300911), received between Nov 24, 2020 and Aug 28, 2024 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2024 - A FEMALE PATIENT RECEIVED GEL-ONE INTO THE KNEE FOR OA. ABOUT 1 HOUR - 1 HOUR HALF AFTER, SHE FELT LIGHT HEADED AND THEN STARTED TO GET HIVES AND THROAT CLOSING UP. SHE TOOK BENADRYL AND GAVE HERSELF AN EPI SHOT. SHE THEN CALLED EMERGENCY CALL #911. (THE DATE IS UNCERTAIN AT THIS MOMENT, BUT COULD BE OF (B)(6) 2024.) THE PATIENT CAME IN WITH HAND GLOVES AND MASK INDICATING SHE ALREADY HAS SEVERE ALLERGIES. SHE HAD PREVIOUS INJECTION OF GEL-ONE IN (B)(6) 2024 WITH NO ISSUES. SHE WAS STILL HAVING ISSUES THAT SHE FELT WAS A RESULT FROM THE INJECTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20086748 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND SWELLING ON LEFT LEG EIGHT DAYS AFTER GEL ONE INJECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16233619 ↗
• InjuryJan 19, 2023Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT IS IN PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 16209084 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXTREME PAIN, DIZZINESS, UPPER RESPIRATORY ISSUES AND WAS UNABLE TO WALK FOUR DAYS AFTER HAVING THE INJECTION. HER ENTIRE BODY STARTED TO VIBRATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE BEING REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Dizziness; Pain; Unspecified Respiratory Problem

  MAUDE report 15157026 ↗
• InjuryJun 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) 2022 - 10:00 AM: PATIENT RECEIVED GEL-ONE INJECTION INTO THE RIGHT KNEE FOR OSTEOARTHRITIS. 10:30 AM: SWELLING AND STIFFNESS OF THE KNEE DEVELOPED. 11:30 AM: SEVERE PAIN AND VERY DIFFICULT TO WALK DEVELOPED. 1:30 PM: HIVES, SEVERE ITCHING AND REDNESS OF THE TRUNK DEVELOPED. PATIENT CALLED THE INJECTION MD BUT ONLY GOT A MACHINE SO LEFT A MESSAGE. PATIENT TOOK 50 MG OF BENADRYL ON PATIENT'S OWN. 2:15 PM: ITCHING SUBSIDED AND SWELLING REDUCED SIGNIFICANTLY SO THAT THE KNEE BENT AND ALMOST NO PAIN WALKING. 3:00 PM: MD OFFICE HAD THE RETURNED CALL ON THE WRONG PHONE AND LEFT A MESSAGE. PATIENT RETURNED THE CALL AND SAID EVERYTHING SEEMED TO BE CLEARING UP AND THAT PATIENT SEEMED FINE. 3:15 PM: WHILE DRESSING AFTER TAKING A SHOWER, PATIENT BEGAN TO FEEL LIGHTHEADED, DIZZY AND NAUSEATED SO TURNED TO SIT DOWN. PATIENT APPARENTLY HAD SYNCOPE AND WOKE UP ON THE FLOOR WITH NO APPARENT BODY INJURIES. PATIENT FELT GERO-LIKE SYMPTOMS AND TOOK TUMS. 3:30 PM: VOMITING AND TREMORS BEGAN. PATIENT CALLED MD AND SPOKE DIRECTLY TO HIM. HE INSTRUCTED PATIENT TO CALL EMS IF PATIENT HAD ANY DYSPNEA. PATIENT ORDERED MEDROL DOSEPAK AT LOCAL PHARMACY BUT PATIENT HAD TO FIND SOMEONE TO GET IT (BAD DEL

  Patient problems: Dizziness; Dyspnea; Erythema; Fatigue; Itching Sensation; Nausea; Pain; Rash; Shaking/Tremors; Swelling/ Edema; Syncope/Fainting; Vomiting

  MAUDE report 14881209 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A GEL-ONE INJECTION ON THE RIGHT KNEE. SUBSEQUENTLY, THE PATIENT EXPERIENCED SWELLING, STIFFNESS, PAIN, DIFFICULTY WALKING, HIVES, SEVERE ITCHING AND REDNESS OF THE TRUNK, FATIGUE, NAUSEA, VOMITING, DIZZINESS, TREMORS, FAINTING, AND DYSPNEA. PATIENT WAS PRESCRIBED METHYLPREDNISOLONE AND TOOK OVER THE COUNTER BENADRYL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dizziness; Dyspnea; Erythema; Fatigue; Itching Sensation; Nausea; Pain; Shaking/Tremors; Swelling/ Edema; Vomiting

  MAUDE report 14717908 ↗
• InjuryMay 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022 - IT WAS REPORTED BY A (B)(6) YEAR-OLD FEMALE PATIENT THAT SHE HAD AN ADVERSE EVENT AFTER GEL-ONE INJECTION OF (B)(6) 2022. SHE STATES THE INJECTION CRIPPLED HER. SHE COULD NOT WALK FOR 2 MONTHS AND IS STILL WEARING A BRACE. HER INJECTION PHYSICIAN TOLD HER SHE HAS OSTEOARTHRITIS.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14414840 ↗
• MalfunctionApr 29, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HER LEG WAS CRIPPLED AND SHE COULD NOT WALK FOR SEVERAL MONTHS POST INJECTION. THE PATIENT IS STILL WEARING A BRACE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14249870 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD GEL ONE INJECTION IN THE LEFT KNEE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING EXTREME PAIN WHEN STANDING OR WALKING AND DISCOMFORT SINCE THE INJECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 14187098 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD GEL ONE INJECTION IN THE LEFT KNEE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING EXTREME PAIN WHEN STANDING OR WALKING AND DISCOMFORT SINCE THE INJECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 14187097 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020 A (B)(6) YEAR-OLD FEMALE PATIENT RECEIVED GEL-ONE INJECTION INTO HER LEFT KNEE. (B)(6) 2020 - SHE REPORTS THAT SHE DEVELOPED ITCHY SKIN APPROXIMATELY 3-4 DAYS AFTER THE INJECTION, AND THEN DEVELOPED HIVES AND A RED, BUMPY RASH ALL OVER HER BODY EXCEPT HER FACE. ON (B)(6) 2020 SHE HAS BEEN ON NUMEROUS ROUNDS OF STEROIDS, ANTIHISTAMINES, CREAMS, ETC. AND HAS NOT HAD ANY RELIEF OF SYMPTOMS. SHE HAS STOPPED OTHER MEDICATIONS THAT SHE HAD BEEN ON AND HER OTHER PHYSICIANS HAVE RULED OUT ANY MEDICATION REACTIONS. ON (B)(6) 2021 SHE IS STILL HAVING PAINFUL HIVES/RASH ALL OVER HER BODY.

  Patient problems: Rash

  MAUDE report 11212228 ↗
• InjuryNov 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  2020-UNK - A MALE PATIENT RECEIVED GEL-ONE. (B)(6) 2020 - THE PATIENT WAS IN HOSPICE. EVENT ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 10892669 ↗
• InjuryNov 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  2020-UNK - A PATIENT HAD A BACK PROCEDURE AND JOINT INJECTIONS OF GEL-ONE, IN THE PAST 30 DAYS. 2020-UNK - EVENT ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 10892502 ↗