Orthovisc 630-254Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10886705023110), received between Jun 29, 2016 and Jul 7, 2021 — classified as 2 deaths, 36 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2021No Apparent Adverse Event; Off-Label Use; No Apparent Adverse Event

  THE FDA REPORTED THE FOLLOWING WHICH WAS REPORTED TO THE FDA ON MW5101384 BY A CLINIC. THE DOCTORS OFFICE CALLED IN A NEW PRESCRIPTION FOR ORTHOVISC FOR ILATERAL KNEE FOR FOUR WEEKS. THE DOCTOR IS AWARE THAT THIS IS OFF-LABEL DOSING AND WANTS TO CONTINUE. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127295 ↗
• MalfunctionJul 6, 2021Patient-Device Incompatibility

  A PATIENT REPORTED THE FOLLOWING TO THE FDA ON MW5101325: PATIENT EXPERIENCED A RASH ON THE BODY AND REPORTED LESIONS ON THE SKIN IN THE THIGH AREA. ITCHING WAS ALSO REPORTED. PATIENT SAW A DERMATOLOGIST AN NEUROLOGIST AND REPORTS USING A UNSPECIFIED CREAM TO TREAT. ADDITIONAL INFORMATION WAS SOLOCITED. SEE H10 FOR ADDITIONAL INFORMATION.

  Patient problems: Itching Sensation; Rash

  MAUDE report 12125567 ↗
• InjuryMar 1, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  BEGAN SWELLING WHOLE LEFT LEG (B)(6) 2020, WENT TO DOCTOR (B)(6) 2020 DUE TO INCREASE SWELLING. DUE TO COMPLICATION FROM INJECTION AND NECESSARY ASPIRATION AND SURGERY, I HAVE INCREASE IMMOBILITY IN LEG. PATIENT REPORTED 2 ASPIRATION. I ORTHOVISC SURGERY WITH OVERNIGHT HOSPITAL STAY.

  Patient problems: Arthralgia; Arthritis; Swelling/ Edema

  MAUDE report 11394878 ↗
• InjuryJan 8, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT VIA PHONE THAT HE RECEIVES 3 INJECTIONS EVERY YEAR, BUT AFTER A FORTH KNEE INJECTION IN SEPTEMBER, PATIENT CAN BARELY WALK. A COUPLE OF WEEKS AFTER THE INJECTION, THE PATIENT REPORTED KNEE PAIN THAT DEVELOPED TO LEG PAIN, FINALLY TO HIP PAIN WITH INFLAMMATION. THE PATIENT HAS GONE THRU BLOOD TESTS WITH CLEAN RESULTS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Arthralgia; Insufficient Information; Pain

  MAUDE report 11140794 ↗
• DeathOct 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY MEDICARE IVR VIA EMAIL THAT THE PATIENT PASSED AWAY. IT WAS CONFIRMED THAT THE PATIENT HAS BEEN ON ORTHOVISC MEDICATION SINCE 2013. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 10740610 ↗
• InjuryMar 25, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT ASSISTANCE GROUP THAT PATIENT STATED SHE IS WAITING FOR A KNEE REPLACEMENT AND NEEDS TO USE THE ORTHOVISC. SHE GOT A DOUBLE BLOOD CLOT AND HAD TO GO TO THE HOSPITAL WHERE SHE RECEIVED PHARMACOLOGICAL TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Disseminated Intravascular Coagulation (DIC); Embolus

  MAUDE report 9881114 ↗
• InjuryFeb 6, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ON 15 JANUARY 2020, (B)(6) FROM (B)(6) CALLED ANIKA TO REPORT THAT SHE WAS EXPERIENCING POSSIBLE ALLERGIC REACTION TO AN ORTHOVISC INJECTION AND IT WAS PROVOKED IN HER KNEE. THE SAME REPORTS WAS RECEIVED FROM THIS PATIENT THROUGH THE FDA MEDWATCH REPORT MW5092019. ON 29 JANUARY 2020, PATIENT PROVIDED ADDITIONAL INFORMATION ON THIS CASE. PATIENT REPORTED HAVING THE ORHOVISC TREATMENT ON (B)(6) 2019 AND ON (B)(6), EXPERIENCE ALLERGIC REACTION (HIVES AND RASHES OVER ENTIRE BODY, SWELLING OF FEET, KNEES, AND CALVES, AND TOES WITH CLEAR LIQUID). PATIENT REPORTED REFUSING THE THIRD INJECTION DUE TO THESE ALLERGIC REACTIONS. PATIENT REPORTED SHE HAD IN THE PAST USED SUPARTZ TREATMENT EVERY SIX MONTHS FOR SEVERAL DECADES BECAUSE SHE NO LONGER HAVE MENISCUS IN EITHER KNEE. PATIENT REPORTED NEVER EXPERIENCING ALLERGIC REACTION AFTER SUPARTZ TREATMENT.

  Patient problems: Edema; Patient Problem/Medical Problem; Swelling

  MAUDE report 9678106 ↗
• InjuryJan 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  WORSENING PAIN IN THE RIGHT KNEE. THE 1ST INJECTION AND 2ND INCREASED PAIN. AFTER 3RD INJECTION HAD SEVERE PAIN AND INCREASED SWELLING. TWO WEEKS LATER, HAD TO GET CORTISONE INJECTION TO DECREASE SWELLING AND PAIN WHICH HAD NO EFFECT. HAD TO TAKE PAIN MED EVERY 6 HRS. WHICH JUST DULLED THE PAIN. HAD PROBLEMS WITH SLEEPING, WALKING. DR( B)(6) STATED MORE THAN ½ OF PTS HAVE MORE PAIN WITH THE INJECTION. HAD EUFLEXXA INJECTION WITH NO PROBLEMS. AFTER 3RD INJECTION, SOLUTION FELT LIKE A HARD ROCK UNDER THE KNEECAP. STILL HAVING MORE PAIN THAN I DID BEFORE THE INJECTION.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 9592774 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THIS SPONTANEOUS REPORT FROM THE UNITED STATES WAS REPORTED BY CONSUMER AND CONCERN (B)(6) YEARS OLD CAUCASIAN FEMALE WHO EXPERIENCE THYROID CANCER, SWALLOWING DIFFICULTIES, RINGING IN HER EARS, COUGHING PROFUSELY, DIZZINESS, VERTIGO, TERRIBLE REACTION TO ORTHOVISC, TRIGLYCERIDES INCREASE AND UNDERDOSE, COINCIDENT WITH VASCEPA. IN 2016 ( REPORTED AS THREE YEARS AGO) THE PATIENT INITIATED VASCEPA, 2 CAPSULES TWICE DAILY, ORAL FOR HYPERTRIGLYCERIDEMIA. IN 2018 ( REPORTED AS ONE YEAR AGO) THE DOSE WAS REDUCED TO 1 CAPSULE TWICE DAILY. (CURRENT LOT NUMBER 7K02784 AND EXPIRATION DATE SEP 2021). IT WAS NOT REPORTED WHETHER THE DOSE REDUCTION WAS INITIATED BY THE PATIENT OF THE PHYSICIAN. MEDICAL HISTORY WAS RELEVANT FOR ARTHRITIS AND HIGH CHOLESTEROL. CONCOMITANT MEDICATION WERE CRESTOR (ROSUVASTATIN), RHEUMATE, (FOLATE, METHYLCOBALAMIN, CURCUMINOID TURMERONE COMPLEX), CELEBREX (CELECOXIB), TIZANIDINE AND GELSYN (HYDRAULIC ACID. SHE HAS AN ALLERGY TO TETRACYCLINE. SHE IS A NON-SMOKER AND DRINKS RED WINE 4-5 TIMES A WEEK. IN (B)(6) 2019, THE PATIENT EXPERIENCED SWALLOWING DIFFICULTIES, RINGING IN HER EARS, COUGHING PROFUSELY, DIZZINESS, VERTIGO AND HIGH BLOOD PRESSURE. A BIOPSY IN HER TH

  Patient problems: Dizziness; Thyroid Problems; Vertigo

  MAUDE report 9121464 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  I WAS PRESCRIBED BY MY DOCTORS OF THE (B)(6) ORTHOPEDICS GROUP YOUR ORTHOVISC TO EASE MY ARTHRITIS PAIN ON MY KNEE. BEFORE THE INJECTION, I WAS WALKING WITHOUT A CAIN OR ANY ASSISTANCE, LIVE IN MY HOUSE ENJOYING MY GOLDEN YEARS GOING SWIMMING WITH FRIENDS WITH A LITTLE PAIN ON MY KNEE. AFTER THE INJECTIONS 3 TO EACH KNEE, THE PAIN IS UNBELIEVABLY UNBEARABLE. I'VE CALLED MY INSURANCE HUMANA; THE PHARMACIST TOLD ME MAYBE 3 TIMES WAS NOT ENOUGH SO THE DOCTOR PRESCRIBED TWO MORE. FINALLY, I'VE BEEN INJECTED 3 ON THE LEFT & 5 ON THE RIGHT KNEE. 2½ MONTHS LATER, I AM CONFINED TO BED WAITING FOR ASSISTANCE EVEN TO GO TO THE RESTROOM. I CANNOT WALK EVEN WITH WALKER. I AM NOT ALLERGIC TO BIRD PRODUCTS; I DO NOT HAVE ANY SKIN INFECTIONS OR DISEASES. YOUR INJECTIONS MESS ME UP BIG TIME. MY PCP ORDERED A MRI TO DETERMINE THE CATASTROPHE OF MY KNEES. I DID IT ON (B)(6) 2019. UP TO NOW MY COPAY FOR MY INSURANCE THE DOCTOR JUST FOR THE INJECTION IS $1000 WITHOUT COPAY FOR DOCTORS MRI AND ASSISTANCE. I CAN'T SLEEP AT NIGHT FROM PAIN. THIS IS A FRIENDLY NOTICE FROM ME TO YOU. I NEED YOUR HELP IN MANY WAYS. IF YOU ALL HAVE AN ANTIDOTE, I HAVE TO HAVE IT. I NEED YOUR HELP TO PAY ALL OF THESE BILLS. I

  Patient problems: No Code Available; Pain

  MAUDE report 8311988 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 (B)(6) PA INJECTED ORTHOVISC TO MY LEFT KNEE CAUSING BURNING PAIN AND BLINDED PAIN. VISIT TO E.R. AT (B)(6) HOSPITAL BECAUSE OF WEAKNESS AND PAIN IN LEFT KNEE GOT WORSE OVERTIME. STRENGTH: 30MG/2ML, QUANTITY: 1 EACH WEEK, 2 INJECTION; FREQUENCY: 1 X WEEK CONSECUTIVE WEEK. REASON FOR USE: ARTHRITIS IN LEFT KNEE. DID THE PROBLEM STOP AFTER THE PERSON REDUCE THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO; DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? DIDN'T RESTART.

  Patient problems: Pain

  MAUDE report 8204436 ↗
• InjuryDec 28, 2018Off-Label Use; No Apparent Adverse Event; Insufficient Device Problem Information; Off-Label Use; No Apparent Adverse Event; Insufficient Device Problem Information

  PRESCRIBER WILL BE USING ORTHOVISC IN TREATMENT OF OSTEOARTHRITIS IN THE RIGHT SHOULDER. RIGHT NOW IT IS ONLY INDICATED IN OSTEOARTHRITIS OF THE KNEE. DOSE OR AMOUNT: 300MG; FREQUENCY: OTHER; ROUTE; INTRA- ARTICULAR; DATES OF USE: (B)(6) 2018; IS THE PRODUCT COMPOUNDED? NO, IS THE PRODUCT OVER THE COUNTER? NO.

  Patient problems: No Code Available; No Information

  MAUDE report 8204418 ↗
• InjuryDec 28, 2018Off-Label Use; No Apparent Adverse Event; Insufficient Device Problem Information; Off-Label Use; No Apparent Adverse Event; Insufficient Device Problem Information

  MD IS INJECTING OFF LABEL INTO THE SHOULDER. DATES OF USE: (B)(6) 2018 - PRESENT. DIAGNOSIS OR REASON FOR USE: (B)(4). IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO.

  Patient problems: No Code Available; No Information

  MAUDE report 8204196 ↗
• InjuryOct 23, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INITIAL REPORT: 24SEPTEMBER2018: IT WAS REPORTED BY A THIRD-PARTY THAT FOLLOWING AN ORTHOVISC INJECTION FROM THE CUSTOMER'S ORTHOVISC SYRINGE, THE PATIENT DEVELOPED AN INFECTION AT THE INJECTION SITE. THE CALLER STATED THAT THEY TOOK CULTURES FROM THE PATIENT. THE CALLER STATED THAT THE SYRINGES ARE KEPT AT ROOM TEMPERATURE. THE CALLER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER. UPDATE 1:(B)(6) 2018 TEST CULTURES YIELDED POSITIVE RESULTS FOR STAPH. UPDATE 2: (B)(6) 2018: PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) AND THE KNEE WAS FLUSHED.

  Patient problems: Bacterial Infection

  MAUDE report 7995018 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA EMAIL BY MITEK'S LEGAL COUNSEL THAT A PATIENT HAD BI-LATERAL INJECTIONS OF ORTHOVISC ON OR ABOUT (B)(6) 2016 FOR OSTEOARTHRITIS. WITHIN A FEW DAYS, EXPERIENCED EXCRUCIATING PAIN IN THE LEFT KNEE ONLY. HE ATTEMPTED TO REVISIT THE FACILITY BUT WAS NOT GIVEN A DATE UNTIL (B)(6) 2016. THE DOCTOR WITHDREW FLUID AND DISCOVERED FROM THE LAB FINDINGS THAT HE HAD A SEVERE INFECTION. HE HAD EMERGENCY IRRIGATION AND DEBRIDEMENT OF HIS LEFT KNEE. HE UNDERWENT A SUBSEQUENT SURGERY (B)(6) 2016.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7939810 ↗
• InjuryJun 27, 2018Missing Value Reason; Missing Value Reason

  CASE RECEIVED ON 27MARCH2018: PATIENT RECEIVED A SINGLE ORTHOVISC INJECTION ON (B)(6) 2018 (TOLERATED WITHOUT DIFFICULTY). ON (B)(6) 2018 PATIENT PRESENTED KNEE PAIN AND WAS TREATED WITH MORPHINE INJECTION AND RX FOR MOTRIN. ON (B)(6) 2018 PATIENT COMPLAINED OF SWELLING AND PAIN, TREATED WITH 40 MG OF KENALOG W/ LIDOCAINE TO REDUCE SWELLING. ON (B)(6) 2018, PATIENT STATES THAT PAIN HAS CONTINUED AND HAS BEEN ORDERED FOR AN MRI. AWAITING MRI RESULTS AS OF (B)(6) 2018. UPDATE INFORMATION LEADING TO MDR FILING RECEIVED ON 06JUNE2018: REACTION OCCURED WITHIN 48 HOURS OF INJECTION. PATIENT WAS TREATED WITH AN INCISION AND DRAINAGE OF THE AFFLICTED KNEE. LOT NUMBER WAS ALSO PROVIDED ON THIS DATE.

  Patient problems: Pain; Swelling

  MAUDE report 7642604 ↗
• InjuryMay 29, 2018Missing Value Reason; Missing Value Reason

  PATIENT HAD FIRST SERIES OF BI-LATERAL KNEE INJECTIONS OF ORTHOVISC ON (B)(6) 2018 FROM LOT NUMBER N170045B WITH NO ISSUES. PATIENT HAD SECOND SERIES OF BI-LATERAL KNEE INJECTIONS OF ORTHOVISC ON (B)(6) 2018 FROM LOT NUMBER N170064A AND N170045B. THE PATIENT NOTICED ON (B)(6) 2018 SWELLING ON ONE KNEE AND WAS DIFFICULT TO STAND. ON (B)(6) 2018, THE SWELLING HAD TRAVELLED DOWN TO HIS CALF. ON (B)(6) 2018 THE PATIENT WENT BACK TO THE DOCTORS. BLOOD WORK WAS TAKEN AND NO INFECTION WAS PRESENT. THE DOCTOR DID DRAIN 60CC OF FLUID, THEN ADMINISTERED AN INTRAMUSCULAR INJECTION TO CALM THE SWELLING. THE PATIENT IS SEEING HIS DOCTOR ON (B)(6) 2018 FOR A FOLLOW UP.

  Patient problems: Pain; Swelling

  MAUDE report 7549310 ↗
• InjuryApr 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA EMAIL BY THE JJPAF GROUP THAT A PATIENT IS CURRENTLY ON ORTHOVIC AND IS IN THE HOSPITAL COMPLAINING SHE CANNOT WALK DUE TO THE SEVERE PAIN IN HER LEGS. SHE HAS BEEN IN THE HOSPITAL FOR A FEW DAYS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 7392090 ↗
• InjuryMar 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT EXPERIENCED INFLAMMATION TO THE RIGHT KNEE AFTER RECEIVING AN ORTHOVISC INJECTION. THE SALES REP STATED THAT THE PATIENT HAD SURGICAL INTERVENTION. THE PATIENT HAD AN ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CASE WAS COMPLETED WITHOUT ANY ISSUES.  ATTACHED IS THE REPORT FOR YOUR REVIEW.

  Patient problems: Synovitis

  MAUDE report 7310629 ↗
• InjuryFeb 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT GOT THEIR SECOND ORTHOVISC INJECTION ON SATURDAY (B)(6) AND TODAY (B)(6) WENT TO THE ER WITH A PRETTY SIGNIFICANT RASH ALL OVER BOTH LEGS, ARMS, LEFT HAND, AND ON HER BACK. THE PATIENT IS IN THE ER RIGHT NOW.

  Patient problems: Rash

  MAUDE report 7302759 ↗
• InjuryOct 19, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AN EMAIL WAS FORWARDED TO MITEK CQG CONCERNING AN ORTHOVISC PATIENT. FROM CONVERSATION WITH MR. MARCUS PIERCE THIS MORNING, WE LEARNED THAT HE HAS HAD 2 INJECTIONS OF ORTHOVISC AND PER HIS PHYSICIAN'S RECOMMENDATION HAS STOPPED THE 3RD INJECTION DUE TO, WHAT THEY BELIEVE TO BE ALLERGY RELATED SYMPTOMS. (B)(6) FIRST NOTICED THE SYMPTOMS AFTER THE 1ST INJECTION, HE SAID THAT THE SYMPTOMS WERE LIKE FLU, THE CHILLS, THE WEAKNESS, THE SHAKES, BUT TAUGHT NOTHING OF IT. THE 2ND INJECTION, PRETTY MUCH THE SAME EXCEPT THAT THIS TIME IT WAS MORE SEVERE AND THAT HE HAD UNCONTROLLABLE SHAKES AND ENDED UP IN THE ER. TESTS WERE DONE AND THE RESULTS POINTED TO POSSIBLE ALLERGIES OF THE ORTHOVISC. (B)(6)., HERSELF A NURSE, WAS A BIT UPSET BECAUSE SHE DID CONTACT THE ORTHOVISC LINE, SPOKE TO THE NURSE THERE AND WAS TOLD THAT SOMEONE WAS GOING TO CALL BACK. IT'S BEEN A WEEK. SHE WOULD LIKE TO SPEAK TO SOMEONE WHO IS KNOWLEDGEABLE WITH THE PRODUCT AND WOULD BE ABLE TO ANSWER HER QUESTIONS.

  Patient problems: Chills; Shaking/Tremors; Weakness

  MAUDE report 6963201 ↗
• InjuryOct 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  RECEIVED LETTER FROM SANOFI AVENTIS: CALLER STATES THAT THE FIRST INJECTION WAS PAINFUL AND ON (B)(6) 2017 SHE WOKE UP CONGESTED AND HAD TO USE HER RESCUE INHALER. CALLER STATES THAT ON (B)(6) 2017 HER "BLOOD PRESSURE WAS 198/96 AND SHE WAS IN SEVERE RESPIRATORY DISTRESS" SO SHE WENT TO THE EMERGENCY ROOM AND WAS DISCHARGED ON (B)(6) 2017. CALLER STATES THAT SHE STILL COULD NOT BREATH SO SHE WENT TO URGENT CARE WHERE THEY PLACED HER ON A 6 DAY REGIMEN OF PREDNISONE. CALLER STATES THAT SHE RECEIVED HER 2ND SYNVISC INJECTION ON (B)(6) 2017 AND HAD DIARRHEA AND CRAMPS THAT NIGHT AND THE FOLLOWING MORNING. CALLER ALSO STATES THAT SHE "HAD A HORRIBLE TIME WALKING AND IT WAS PAINFUL". CALLER STATES THAT ON (B)(6) 2017 SHE SAW THE PULMONOLOGIST AND SHE "COULD HARDLY WALK AND COULD NOT HARDLY BREATHE". CALLER STATES THAT SHE RECEIVED HER 3RD SYNVISC INJECTION THE WEEK OF (B)(6) 2017 AND FOLLOWING THAT INJECTION HER "KNEE WAS SWOLLEN, WITH PUFFINESS OVER THE KNEE THAT WOULD GET HARD AND THEN GO AWAY". CALLER STATES THAT SHE WAS ALSO EXPERIENCING INSOMNIA AND ONLY SLEEPING 1-2 HOURS PER NIGHT. CALLER STATES THAT SHE WAS ALSO MANIC. CALLER STATES THAT SINCE HER FIRST SYNVISC INJECTION ON (B)(

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 6912087 ↗
• InjurySep 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  "DEPUY MITEK QUALITY DEPARTMENT RECEIVED A MEDWATCH FORM FROM THE SPINE GROUP ON 8-28-2017 WITH THE FOLLOWING EVENT DESCRIPTION. RECEIVED 3 ROUNDS OF ORTHOVISC KNEE INJECTIONS AT (B)(6) 2016. WITHIN ONE WEEK, STARTED HAVING SEVERE HEART ARRYTHMIAS. HAD A PREVIOUS HISTORY OF ARRYTHMIA AND SVT, BUT MY HEART DOCTOR SAID IT WAS NEVER CONSISTENT ENOUGH TO TREAT IT. AFTER THE KNEE INJECTIONS, I VISITED MY HEART DOCTOR WITH THE INCREASED SYMPTOMS. HE WANTED ME TO WEAR A HEART MONITOR FOR ONE MONTH. AFTER ONE WEEK, HIS OFFICE CALLED AND SAID THEY HAD ALL THE INFO THEY NEEDED, HAD ME RETURN TO HIS OFFICE AND SCHEDULED A HEART ABLATION FOR 3 MONTHS OUT. HEART ABLATION HAPPENED IN (B)(6) AND WAS UNSUCCESSFUL. THREE AND A HALF MONTHS LATER, I HAD A STROKE ON (B)(6) AND WAS HOSPITALIZED FOR 4 DAYS. ALL TESTS CAME BACK NEGATIVE FOR ANY EXPLANATIONS. AS OF YET, THERE IS NO EXPLANATION FOR MY STROKE. I AM (B)(6), NOT OVERWEIGHT AND IN PRETTY GOOD HEALTH. I EXERCISE 3 TIMES A WEEK. I AM ON BLOOD PRESSURE DAILY FOR HYPERTENSION AND IT IS WELL CONTROLLED. I STILL HAVE TO F/U WITH MY PCP AND NEUROLOGIST NEXT WEEK, AT WHICH TIME I WILL DISCUSS THE POSSIBLE LINK BETWEEN THE ORTHOVISC INJECTION AND MY ST

  Patient problems: No Code Available

  MAUDE report 6888476 ↗
• InjuryAug 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED VIA PHONE THAT AFTER RECEIVING ONE INJECTION OF ORTHOVISC ON (B)(6)2017 IN EACH OF HER KNEES, SHE HAS HAD A REACTION CAUSING HER EYES AND LIPS TO SWELL UP. SHE ALSO STATED THAT SHE HAS A RASH ON HER NECK THAT IS BUMPY AND HAS GOTTEN WORST. HER KNEES ARE FINE SHE STATED. THE PATIENT FOLLOWED UP WITH THE DOCTOR WHO ADVISED HER TO SEE HER GENERAL PHYSICIAN. SHE HAS BEEN TAKING BENADRYL, ZYRTEC, AND PREDNISONE. THE PATIENT HAS AN ALLERGY TO ASPIRIN AND SULFUR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Rash; Swelling

  MAUDE report 6817701 ↗
• DeathAug 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  "THE CUSTOMER REPORTS THAT IN 2015, HER MOTHER (THE PATIENT), DIED TWO WEEKS AFTER RECEIVING ORTHOVISC INJECTIONS IN HER RIGHT KNEE FOR KNEE PAIN. THE REPORTER ALSO STATES THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, DIARRHEA, AND SHORTNESS OF BREATH IN THE TWO WEEKS PRIOR TO HER DEATH. PRIOR TO RECEIVING THE ORTHOVISC, THE PATIENT CONTACTED THE CLINIC TO INFORM THE CLINIC ABOUT ALL OF HER MEDICAL ILLNESSES AND COMPLICATIONS. THE PATIENT FURTHER EXPLAINED TO THE CLINIC SOME OF HER ALLERGIES AND THE PATIENT WAS TOLD THAT IF ONE IN PARTICULAR (ALLERY) HAD GONE INTO HER BLOODSTREAM THAT IT COULD CAUSE DEATH. DURING THE SAME CONVERSATION BETWEEN THE PATIENT AND THE CLINIC, THE PATIENT REQUESTED PRODUCT INFORMATION TO PRESENT TO HER NEPHROLOGIST/DOCTOR FOR REVIEW. THE PATIENT'S MEDICAL CONDITIONS/HISTORY INCLUDE: KIDNEY DISEASE, CHRONIC HEART FAILURE, AND UNSPECIFIED ALLERGIES.THE REPORTED DATES OF THE INJECTIONS ARE: 1ST IN (B)(6) 2015 AND 2ND IN (B)(6) 2015. THE REPORTED DATE OF DEATH IS (B)(6)2 015."

  Patient problems: Death

  MAUDE report 6789533 ↗