inforMED
InjuryMOZ

SUPARTZ FX (SODIUM HYALURONATE) INJECTION

Received Nov 13, 2024 · Event occurred Nov 4, 2024

Report MW5162520 · MDR key 20687267

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc.

Patient

64 YR · Female

  • Dehydration
  • Diarrhea
  • Fever
  • Headache
  • Muscle Weakness/Atrophy
  • Nausea
  • Pain
  • Vomiting
  • Dizziness
  • Ambulation or Postural Difficulties
  • Dehydration
  • Diarrhea
  • Fever
  • Headache
  • Muscle Weakness/Atrophy
  • Nausea
  • Pain
  • Vomiting
  • Dizziness
  • Ambulation or Postural Difficulties

Narrative

Description of Event or Problem

MY WIFE HAD A SEVERE REACTION TO A SUPARTZ KNEE INJECTION. THIS WAS THE FIRST OF FIVE INJECTIONS SHE WAS SCHEDULED TO RECEIVE FOR SEVERE OSTEOARTHRITIS IN HER LEFT KNEE. WITHIN ABOUT AN HOUR OF RECEIVING THE INJECTION ON MONDAY (B)(6), WHICH WAS INTENDED TO RELIEVE PAIN DUE TO ARTHRITIS IN THE KNEE, SHE HAD A HEADACHE, DIZZINESS, NAUSEA AND DIARRHEA. SHE ALSO SAID SHE HAD A STRANGE TASTE AND SMELL OF MEDICINE. THE KNEE THAT WAS TREATED BECAME WEAKER THAN IT HAD BEEN AND SHE WAS UNABLE TO NAVIGATE STAIRS AT ALL, WHERE PREVIOUSLY SHE WAS ABLE TO DO SO WITH A LITTLE EXTRA EFFORT. THE VOMITING AND DIARRHEA CONTINUED TO THE POINT WHERE 4 DAYS LATER (ON FRIDAY (B)(6)) SHE WAS SO SEVERELY DEHYDRATED AND WEAK FROM NOT BEING ABLE TO HOLD DOWN ANY FOOD OR LIQUIDS, SHE HAD TO BE TAKEN TO THE (B)(6) HOSPITAL EMERGENCY ROOM. THE HOSPITAL PERFORMED LAB WORK OF BLOOD AND URINE AND DID A CT SCAN TO RULE OUT BRAIN OR HEAD INJURY. THERE WERE NO INDICATIONS OF INFECTION, COVID, INFLUENZA OR OTHER CAUSE OF HER SYMPTOMS. DUE TO THE SYMPTOMS AND TIMING OF ONSET, THE ER DOCTOR SUSPECTED SHE HAD A STRONG INTOLERANCE TO THE INJECTION, AND HE MENTIONED THAT HER SYMPTOMS ARE NOTED AS A LESS COMMON SIDE EFFECT IN THE PRODUCT LITERATURE. THE HOSPITAL ADMINISTERED IV FLUIDS AND ANTI-NAUSEA MEDICATION AS WELL AS PRESCRIBED ANTI-NAUSEA MEDICATION FOR USE AT HOME. THE ER DOCTOR SAID HE DIDN'T KNOW HOW LONG IT MAY TAKE FOR THE INJECTION TO WORK ITS WAY OUT OF HER SYSTEM. SHE CONTINUED TO HAVE THE HEADACHE, NAUSEA AND VOMITING, BUT TO A LESSOR DEGREE. ON (B)(6) AT APPROX 2AM, SHE HAD A FEVER SPIKE TO 103.1 F, INCREASED PAIN AT THE INJECTION SITE AND THE LEG AREA ABOVE IT. SEVERE HEADACHE AND NECK PAIN. SHE SAID HER BODY FELT LIKE IT WAS GOING TO EXPLODE. SHE TOOK IBUPROFEN AND TYLENOL AND PUT ICE PACKS AND COLD WASH CLOTHES ON HER BODY TO COOL IT DOWN. FEVER AND PAIN SUBSIDED BY ABOUT 6:30AM. AS OF TODAY, 7 DAYS LATER, MONDAY (B)(6), SYMPTOMS REMAIN, ALTHOUGH LESS SEVERE. SHE IS WEAK BUT STARTING TO TOLERATE SOME FOOD AND IS ABLE TO HOLD DOWN LIQUIDS AND CONTINUES TO HAVE RE-OCCURRING PAIN. WHEN I CONTACTED THE DOCTOR THAT PROVIDED THE TREATMENT TO NOTIFY HIM OF THE REACTION, (DR. (B)(6), ASSOCIATED ORTHOPEDISTS OF (B)(6).) HE SAID HE HAD NEVER SEEN THAT REACTION BEFORE AND DOWNPLAYED IT AS NOT LIKELY DUE TO THE INJECTION. SHE HAD A WELL CHECK UP VISIT WITH HER PRIMARY CARE DOCTOR THE FRIDAY BEFORE ((B)(6)) AND HAD NO SIGNS OF ILLNESS PRIOR TO THE KNEE INJECTION AND SUSPECTED REACTION. SHE HAD NOT HAD A MEAL IN THE PRIOR 12-15 HOURS, SINCE THE EVENING BEFORE THE INJECTION, WHICH WAS DONE APPROX 1:30 PM MONDAY AFTERNOON ON (B)(6). HOSPITAL EMERGENCY ROOM PERFORMED STANDARD BLOOD, URINE AND CT SCAN OF HEAD AND NECK. REASON FOR USE: REDUCE PAIN, IMPROVE MOBILITY.