MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number UNKNOWN

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Joint Swelling (2356); Joint Disorder (2373)

Event Date 11/10/2017

Event Type  Injury  

Event Description

Device malfunction [device malfunction] , fluid buildup in and around her knees [knee effusion], swelling of her knees [knee swelling] , experienced adverse effects from synvisc-one.[unevaluable event] , chills [chills] , redness [redness].Case narrative: based on the information received on (b)(6) 2018 from physician, this case is initially considered as non-serious is now updated to serious as serious events device malfunction, fluid buildup in and around her knees were added.Additionally, this case has become medically confirmed.This unsolicited case from united states was received on (b)(6) 2018 from other non-health care professional this case concerns a (b)(6) female patient who initiated treatment with synvisc one and after unknown latency patient experienced adverse effects from synvisc-one, swelling of her knees (latency: 1 day), fluid buildup in and around her knees (latency: 1 day|), chills (latency: 1 day) and redness (latency: 1 day), swelling of her knees (latency: 1 day) and also, device malfunction was identified for the reported lot number.Concomitant medications included ascorbic acid (vitamin c), aspirin, fenofibrate micronized (lofibra) for triglycerides, ibuprofen (advil, motrin), levothyroxine (synthroid), multivitamin (theragran), potassium chloride sa (k-dur, klor-con), atorvastatin (lipitor) for cholesterol, benazepril-hydrochlorthiazide (lotensin hct), levothyroxine (synthroid), oxybutynin (ditropan-xl), diclofenac sodium 1% gel.Patient had a medical history of cataract, hyperlipidemia, hypertension, hypothyroid.Patient had a surgical history of appendectomy, breast biopsy (left), breast lumpectomy (left), eye surgery (cataract removal), hysterectomy, knee surgery (bilateral); (b)(6) 2015; stem cell completed), thyroid lobectomy, tonsillectomy, chronic pain of left knee, chronic pain of right knee, difficulty walking, renal insufficiency, gastroenteritis, exploratory laparotomy for right ovarian teratoma, impaired fasting glucose, obesity, colonic polyps.Patient is a smoker (the patient smoked 0.25 packs/day for 50 years) and patient never used smokeless tobacco.Patient uses alcohol (take 1.8 oz total alcohol per week; 1 glasses of wine, 1 cans of beer, 1 shots of liquor).Patient uses no drugs.Patient has a family history of breast cancer (maternal aunt), hypertension (mother).Patient had allergy to iodinated contrast (rash), allergy to ibuprofen (ltch), allergy to nsaids (non-steroidal), penicillin allergy (ltch).On (b)(6) 2017 at 12:57 pm, patient received treatment with intra articular synvisc one injection at a dos of 6 ml once (batch/lot number: 7rsl021; expiration date: 31-may-2020).For primary osteoarthritis of both knees in the both left and right knee.On (b)(6) 2017 (after 1 day of receiving synvisc one), the patient experienced swelling of her knees, fluid buildup in an around her knees, chills, and redness.On an unknown date, latency unknown, patient experienced adverse effects from synvisc one.Corrective treatment: triamcinolone acetonide injection for fluid buildup in and around her knees, swelling of her knees; not reported for rest of the events.Outcome: unknown for experienced adverse effects from synvisc one; recovered for other events seriousness criteria: required intervention for fluid buildup in and around her knees, swelling of her knees, device malfunction a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Additional information was received on 06-mar-2018: global ptc number and results were added.Additional information was received on 07-may-2018 from physician.Age of patient was added.Synvisc one dose, frequency, indication, batch/lot number (7rsl021) and expiration number was added.Event device malfunction, fluid buildup in and around her knees, chills and redness was added.Medical history, family history, personal history, drug allergies and concomitant medication were added.Clinical course was updated.Text was amended accordingly.Follow-up was received on 10-may-2018.No new information was received.Follow-up information was received on 15-may-2018.No new information was received.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7584219
• MDR Text Key: 110585985
• Report Number: 2246315-2018-00478
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 87