• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Aspiration/Inhalation (1725); Erythema (1840); Fatigue (1849); Synovitis (2094); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment dated (b)(6) 2018: this case concerns a patient who was on treatment with synvisc one and later it a device malfunction was noted for reported batch number. The relationship of the event with suspect cannot be denied. However, further information regarding patient¿s current clinical presentation, onset latencies and other risk factors will aid in the complete medical case assessment.
Event Description
Device malfunction [device malfunction] ; 35cc blood tinged fluid aspirated [joint effusion] ; swelling [swelling of l knee] ; left knee pain/joint pain/medial patellar facet/lateral patellar facet tender [knee pain] ([condition aggravated]). Case narrative: initial information received from united states on (b)(6) 2018 regarding an unsolicited valid serious malfunction case received from physician. This case involves (b)(6) male patient who experienced 35cc blood tinged fluid aspirated, swelling and left knee pain/joint pain/medial patellar facet/lateral patellar facet tender (latency: unknown), while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). Also device malfunction was identified for the reported lot number. The patient's past medical history included right elbow surgery in (b)(6) 1997, (b)(6) 1998 and (b)(6) 1999, staph infection in 1999, surgery staph infection surgery left leg achilles tendon surgery in (b)(6) 1999, deviated septum repaired in (b)(6) 2007, right hamstring repair in (b)(6) 2013, exploration of right sciatic nerve, revision right hamstring repair, removal of heterotopic ossification and sciatic neurolysis on (b)(6) 2016, right arthroscopic acetabuloplasty, notchplasty, labral repair, ligamentum teres debridement, iliopsoas bursectomy, femoroplasty and capsular plication on (b)(6) 2017, diverticulitis, sleep apnea, anxiety, depression, and diphenhydramine hydrochloride (benadryl) allergy. Patient was a former smoker. The patient reports a family history of: anxiety: sibling; cancer: sibling, other, father; diabetes type 1: father, other; depression: sibling; high blood pressure: sibling, mother, father; seizures: other, father. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, he continues to experience anterior, lateral and subpatellar pain. Concomitant medications included temazepam; gabapentin; acetylsalicylic acid (aspirin); oxycodone hydrochloride (roxicodone) for pain; paracetamol (tylenol extra-strength); atorvastatin calcium; sertraline hydrochloride (zoloft); clonazepam; bupropion hydrochloride (buproban); orphenadrine citrate; levothyroxine sodium (l-thyroxine); paracetamol (tylenol); and hydrocodone bitartrate, paracetamol (norco) for pain. Patient also complained of hip pain. On (b)(6) 2017, left knee exam revealed flexion was 135, patient was well-nourished and well-developed, white sclera, teeth and gums were normal, breathing was easy, skin normal over the affected area, normal sensation and pulses distally. On the same day, at 10:02 am, the patient started using hylan g-f 20, sodium hyaluronate injection in the left knee, at dose of 6 cc, intra-articular (lot - 7rsl021, expiration date: may-2020) for knee pain, arthritis and/or intraarticular derangement. The left knee was visualized under ultrasound from a supero-lateral approach. Under sterile conditions, a 22-gauge needle was inserted under ultrasound guidance into the knee. The synvisc injection was distributed throughout the knee. Care was taken to avoid the cartilage surfaces. Ultrasound imagery of the injection site was obtained, and appropriate images were labeled, saved and permanently archived. No complication was experienced. Assessment showed left knee pain in the setting of chondromalacia patella and osteoarthritis. On (b)(6) 2018, patient had left knee open patella femoral unicompartmental arthroplasty with robotic assistance. On an unknown date, patient had knee pain (latency: unknown). On (b)(6) 2018, patient had an increase in left knee pain and swelling (latency: unknown). On (b)(6) 2018, it was reported that left knee pain decreased from previous exam. The patient complains of dull pain about the anterior aspect. The patient describes the pain as being a 6 out of 10 on a 10 point pain scale. He has been compliant with post-operative activity restrictions. (b)(6) continues to take narcotics for pain control. He denies fevers, chills, sweats, numbness, tingling and electric shocks. General review of system was normal except musculoskeletal which showed joint pain (latency: unknown). It was reported that incision was healed. Also, on the same day, physical examination showed tender medial patellar facet and lateral patellar facet (latency: unknown). On the same day, 35 cc blood tinged fluid was aspirated. Final diagnosis was left knee pain/joint pain/medial patellar facet/lateral patellar facet tender, swelling, 35cc blood tinged fluid aspirated and device malfunction. Corrective: paracetamol (tylenol) for left knee pain/joint pain/medial patellar facet/lateral patellar facet tender, swelling; not reported for rest of the events outcome: unknown for all events seriousness criteria: medically significant for device malfunction 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
bridgewater, NJ 08807
MDR Report Key7917783
MDR Text Key124820731
Report Number2246315-2018-00603
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2018 Patient Sequence Number: 1