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Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Fever (1858); Hyperglycemia (1905); Pain (1994); Synovitis (2094); Blurred Vision (2137); Chills (2191); Dizziness (2194); Hypoesthesia (2352); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Date 11/27/2017
Event Type  Injury  
Manufacturer Narrative
Sanofi company comment dated 20-sep2018. Patient developed right knee medial tear and right knee pain and underwent surgery and received steroid injection for the same. Based on limited information provided, causal role of suspect product cannot be excluded. Case will be re-evaluated post further update on the patients underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
Event Description
Right knee medial meniscus tear [tear of medial cartilage or meniscus of knee, current] ([joint lock]). Right knee pain [knee pain] ([diffuse pain], [condition aggravated]). Significant discomfort [discomfort]. Ambulates with limp [limping]. Hears popping [joint clicking]. Limits adls like standing and walking [activities of daily living impaired]. Swelling [joint swelling]. Case narrative: initial information received on 13-sep-2018 from united states regarding an unsolicited valid serious case received from a consumer. This case involves a (b)(6) years old female patient who experienced right knee medial meniscus tear, right knee pain, significant discomfort, ambulates with limp, hears popping, limits adls like standing and walking and swelling, after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history included pap smear in 1983, asthma, colon polyp in 2016, depression on (b)(6) 2015, heartburn, ovarian cyst, neuromuscular disorder on (b)(6) 2015, thyroid disease, breast reduction surgery (b)(6) 2012, hysteroscopy, biopsy lung, thyroidectomy in (b)(6) 2002, cranial nerve decompression, uterine fibroid surgery, sulfa drug allergy, bactrim allergy, mri of knee on (b)(6) 2017 and tubal ligation. The patient's past medical treatment included synvisc one in left knee which provided complete relief. The patient's past vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing bilateral knee osteoarthritis. Patient is a non-tobacco user concomitant medications included paracetamol (tylenol [paracetamol]); salbutamol (proventil hfa [salbutamol]); azithromycin (zithromax); bupropion hydrochloride (wellbutrin); fluticasone propionate (flovent hfa); loratadine (claritin [loratadine]); metformin hydrochloride (glucophage); montelukast sodium (singulair); and levothyroxine sodium (synthroid). On (b)(6) 2017, patient received intra-articular injection of synvisc one (hylan g-f 20, sodium hyaluronate) in her right knee joint at 6ml 1x (batch number: unknown) for bilateral knee osteoarthritis. The injection site was sterilized and synvisc-one was injected. The patient tolerate the procedure well. On (b)(6) 2017, patient reported to the emergency department with right knee pain (latency: 11 days) and complained of increasing pain and swelling (latency: 11 days). The patient was prescribed naprosyn for pain. On (b)(6) 2017, patient reported to the clinic and stated that her pain was improving since her last visit but she was still in discomfort (latency: unknown). Further, she had catching and locking of her knee and also heard popping (latency: unknown) and ambulates with as limp (latency: unknown). The pain rated at 2/2. An mri was performed to evaluate the pathology of catching and locking symptoms. The patient also reported that after receiving the injection she has had difficulty ambulating and ambulates with limp (latency: few days) and has diffuse pain throughout the knee. On (b)(6) 2017, patient reported to the clinic with results of the mri. It was noted that the medial meniscus had flipped and there was disruption of the deep fibres and tearing of the anterior fibres at level of the joint. The patient stated that she wanted to proceed with surgery as all conservative treatments had failed. The risk and benefits of the surgery were discussed with the patient in detail. On (b)(6) 2017, patient underwent partial right knee medial meniscectomy for the right knee medial tear (latency: unknown). The patient was prepped for surgery in sterile fashion and general anesthesia was induced and preop antibiotics were given. An inferolateral portal was created with a scalpel, camera was introduced using a blunt trocar into the superolateral pouch. The trochlear groove was visualized and synovitis was noted which was debrided. The medial compartment was visualized and a degenerative tear was detected on medial meniscus. A inferomedial portal was created with the blade again, area was probed and biters and shavers were used to debride the meniscal flap down to smooth edges. The portals were closed with 3-0 nylon interrupted sutures and 10% of bupivacaine was infiltrated around each portal. The patient was awakened and sent to postoperative care unit in stable condition. On (b)(6) 2018, patient reported for follow up on her surgery and stated that the pain was well controlled, further her incision was healing well with no drainage. On (b)(6) 2018, patient had a steroid injection for pain which provided some relief but she continued to have pain that limits even simple adls like standing and walking (latency: unknown). On (b)(6) 2018, patient reported again for follow up on her surgery and stated she had pain on 10/10 which affected her quality of life and was in a lot of discomfort. Corrective treatment: partial right knee medial meniscectomy for the right knee medial tear; steroid injection and naprosyn for right knee pain; not reported for rest. Seriousness criterion: required intervention for right knee medial tear and right knee pain. Outcome: not recovered for right knee pain and discomfort; unknown for rest. A product technical complaint was initiated and results are pending for the same.
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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 Key7918353
MDR Text Key122049286
Report Number2246315-2018-00602
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 02/27/2019
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 NumberUNKNOWN
Was Device Available for Evaluation? No
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