MAUDE Adverse Event Report: WYETH LABS (RA) / GENZYME CORPORATION SYNVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Pain (1994); Swelling (2091); Burning Sensation (2146)

Event Date 01/01/2002

Event Type  Injury  

Event Description

The patient's experience (ovarian cyst) was considered medically important.Information has been received from a (b)(6)-year-old female patient.The patient's concurrent illnesses include hypothyroidism (for 4 years), hypertension nos (for 2 years), and seasonal allergies (she is not allergic to birds, feathers, or eggs).Past history included 3 synvisc series (joint injection), dates of therapy unknown.Therapy with synvisc (hylan g-f 20 fluid) for localized osteoarthritis consisted of one 2 ml injection in each knee every week for three weeks in 2002 (4th series).Dosage was repeated in each knee every week for 2 weeks, on (b)(6) 2003 and on (b)(6) 2003 (5th series).All 5 series were given over a 3 year period.Additional suspect medication included prempro (conjugated estrogens/medroxyprogesterone acetate); dosage was 0.625/5 mg taken daily for 4 months and discontinued over a year ago (date unknown, presumably in 2002).Concomitant therapy included synthroid (levothyroxine sodium), altace (ramipril), and allegra (fexofenadine hydrochloride).Within several hours after the 2nd injection (4th series) in 2002, the patient experienced excruciating pain in the right knee (arthralgia) which had become "hugely swollen" (joint swelling) and wouldn't bend for 2 days.The knee was better on the 3rd day, and she had no complications after the 3rd injection in 2002.By 11:00 pm on (b)(6) 2003, (5th series), she experienced excruciating pain, which was worse in the left knee.She also stated she was "burning up" (feeling hot) but had no fever on (b)(6) 2003.She missed the next 2 days of work, and used a cane through (b)(6) 2003.The patient also reported the synvisc treatments have only lasted for 4.5 months (drug effect decreased).She also developed a "huge ovarian cyst" (ovarian cyst) and had no (menstrual) periods (amenorrhoea nos) during the 4 months of prempro therapy.She had gone to the emergency room with severe abdominal pain.Results of a computerized tomogram revealed an ovarian cyst.She was treated for pain and released.Her menstrual period resumed within 4 days, and ultrasound scan indicated the cyst was completely gone in 3 weeks.Ovarian cyst (llt: ovarian cyst); arthralgia (llt: arthralgia).Feeling hot (llt: feeling hot), amenorrhoea nos (llt: amenorrhea).Drug effect decreased (llt: drug effect decreased); joint swelling (llt: joint swelling).

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): WYETH LABS (RA) / GENZYME CORPORATION
• MDR Report Key: 10829236
• MDR Text Key: 216190583
• Report Number: MW5097794
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/02/2003

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 77