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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Inflammation (1932); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Event Description
Device malfunction. Flare up (condition aggravated). Acute inflammatory reaction/psuedoseptic reaction (inflammatory reaction), (knee effusion), knee pain), (knee swelling), (stiff knees), (discomfort in joints), (antalgic gait), (synovial fluid analysis abnormal). Significant pain with difficulty walking (difficulty in walking). Range of motion 10-90 (joint range of motion decreased). Instability (joint instability). Weakness. Night sweats. Nausea. Heartburn. Swelling lower extremities (swelling of legs). Muscle weakness. Maculopapular erythematous lesions to bilateral knees (maculopapular rash), (erythema). Bone contusion in the medial femoral condyle and tibial plateau (bone contusion). Large popliteal cyst (popliteal cyst) complex tears in the posterior horn, body and root of the medial meniscus (meniscus tear). Baker's cyst. Joint pain. Case narrative: this unsolicited case from unites states was received on (b)(6) 2018 from a healthcare professional. This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after few months had device malfunction, flare up, acute inflammatory reaction/psuedoseptic reaction, instability, weakness, nausea, nausea, swelling lower extremities, muscle weakness, maculopapular erythematous lesions to bilateral knees; after 294 days had significant pain with difficulty walking, range of motion 10-90; after an unknown latency had night sweats, bone contusion in the medial femoral condyle and tibial plateau, large popliteal cyst, complex tears in the posterior horn, body and root of the medial meniscus, baker's cyst and joint pain. Family history: deep-vein thrombosis (dvt), father had asthma and rheumatoid arthritis; father and grandmother had coronary artery disease and heart disease, mother had high cholesterol, rheumatic fever, hypertension and kidney disease. Medical history: arthroscopy of the right, left knee in 2010 (2014). Other previous surgeries include hysterectomy in 2004. L tibial plateau, fracture treated nonoperatively in 2006 (fracture repair of the left knee), bl meniscal surgery (b)(6) 2010 / l dec 2014 vs 2015. The patient had been diagnosed with early bilateral mild-to-moderate osteoarthritis status post left knee partial medial meniscectomy and abrasion arthroplasty on (b)(6) 2016. Patient had posterior leg pain severe in past couple years, dvt u/s had been negative. The patient had allergies to narcotics, took multiple csi, ha shots (therapeutic injections), was allergic to numerous medications that included: diphenhydramine hydrochloride (benadryl), codeine, minocycline, morphine, synvisc, tetracyclines, penicillins, sulfa (sulfonamides), and naproxen (vimovo). Patient had done cortisone injections with aspiration in (b)(6) 2017 by urgent care, did not help, only lasted 1 week. Prior treatments include anti-inflammatory: naproxen sodium (aleve): helps somewhat; paracetamol (tylenol), cane use (no), brace use (patellar sleeve brace uncomfortable), physical therapy (did not help). The patient drinks alcohol socially (1-2 drinks per week). She never used tobacco. Past or present drug use includes: do not use drugs. On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection once (dose: not provided) bilaterally for primary arthritis bilateral knees that provided short relief of symptoms, but the patient did not follow up after six weeks as 1 had recommended. She presented to the office on (b)(6) 2017, complaining of significant bilateral knee pain that was not getting better. She had severe bilateral knee pain that was constant (b)(6) 2010. She denied any back pain, hip pain or paresthesias in her lower extremity. Despite all the conservative measures and home exercise program, she continued to have knee pain. She has had viscosupplementation in the past that only provided mild relief of symptoms. Physical examination: constitutional: healthy, appearing stated age; well developed, well nourished. Cognitive: alert and oriented times three with normal mood and affect. Neurologic: normal sensation and motor function. Skin: head, neck, and extremities skin is warm, dry, and intact without rashes or lesions. Lymphatics: no evidence of lymphadenopathy on the neck or axilla. Neck: no masses, symmetric, trachea midline. Respiratory: rate, rhythm and effort within normal limits. Cardiovascular: peripheral pulses 2+ bilaterally, no edema. Musculoskeletal: physical exam of bilateral knees demonstrates range of motion of 5-125 degrees with trace joint effusion. Good quadriceps and hamstring strength. Negative straight leg raise with no pain during hip range of motion. No medial or lateral joint line pain. No pain with meniscal provocative testing. Normal patellar glide with mild peripatellar pain. 2+ distal pulses and intact sensation and motor function. No calf swelling and no edema bilaterally. The plan included: at this point, mri of bilateral knees would be obtained to better assess her significant life altering pain. The patient completed a series of viscosupplements, which gave moderate relief for bilateral degenerative knee pain, which interfered with activities of daily living. It was recommended that the patient had a repeat course of viscosupplementation to be scheduled no sooner than six (6) months from the date of the last series. On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection at a dose of 6 ml once (lot number: 7rsl021; expiration date: not provided) into the right knee for primary arthritis bilateral knees. The right knee was sterilely prepped and the joint was injected. The patient tolerated the procedure well; post injection instructions were given. Bilateral knees aspirated 20 cc of clear yellow synovial fluid prior to synvisc-one injections. Follow up to be done in six months. On an unknown date in 2017, after an unknown latency, patient was having increasing pain as well as pain at night. She had a recent magnetic resonance imaging (mri) of both knees done today, which was reviewed. Mri of the left knee done today and images reviewed today with the patient shows moderate effusion, baker's cyst, tricompartmental degenerative joint disease (djd) worse in the medial and patellofemoral compartments with degenerative medial meniscal tear. Mri left knee impression: mild osteoarthritis, complex tears in the posterior horn and root of the medial meniscus, mcl and acl strain, large joint effusion, bone contusion in the medial femoral condyle and tibial plateau and large popliteal cyst. Mri of the right knee as well done today and images reviewed with today with the patient showed moderate effusion, mri impression showed complex tears in the posterior horn, body and root of the medial meniscus, mcl strain, moderate osteoarthritis and chondromalacia patella, large joint effusion, bone contusion in the medial femoral condyle, tibial plateau and proximal mid tibia. A microfracture cannot be excluded. She had tricompartmental djd with edema in the medial tibial plateau, medial femoral condyle and tibial spine with significant patellofemoral degenerative changes and degenerative medial meniscal tear. Physical examination: exam today showed full range of motion bilaterally 1+ effusions and diffuse anterior medial knee pain with minimal symptoms on provocative meniscal testing, no instability. No swelling. Normal gait and station. Symmetric hip range of motion and negative straight leg raise. Technique used: stir axial, t1 stir coronal, stir double echo t2 sagittal images were obtained through the knee that showed: menisci: there was marked deformity noted to the posterior horn of the medial meniscus with complex abnormal signal involving superior and inferior articular surface and extending into the root of the meniscus. There is truncation to the apex of the posterior horn of the medial meniscus. The lateral meniscus was intact. Ligaments: there was edema noted superficial to the medial collateral ligament. The lateral collateral ligament was intact. There was mild edema seen throughout the course of the anterior cruciate ligament. Intact fibers are noted. The posterior cruciate ligament was intact. The medial and lateral patellar retinaculum was unremarkable. Tendons and extensor mechanism: the distal quadriceps tendon and the medial and lateral patellar retinaculum are intact. The patellar tendon was intact. Osseous structures and bone marrow: there was moderate amount of marrow edema within the medial femoral condyle and medial tibial plateau. No evidence for fracture or osteochondritis dissecans. Joint spaces and soft tissues: there was a large suprapatellar joint effusion. No intra-articular loose body was seen. There was a large septated popliteal cyst. There was mild medial compartment joint space narrowing and spurring with thinning of the articular cartilage overlying the medial femoral condyle and medial tibial plateau. The treatment plan included conservative treatment: nsaid, low impact pt strengthening exercises and continue activities as tolerated and contact the office with any questions. To follow up or call sooner if any problems arise. On (b)(6) 2017, the patient presented for follow up complaining of significant pain with difficulty walking, big swollen knee. She was afebrile. Physical examination:musculoskeletal: physical examination of bilateral knees demonstrates antalgic gait and range of motion 10-90 degrees due to pain. Afebrile and 3+ joint effusions stable. 2+ distal pulses, intact sensation and motor function, no calf swelling and no edema. After discussion with the patient regarding treatment options, a mutual decision was made to proceed with an aspiration/injection of the bilateral knees joint. The bilateral knees were sterilely prepped, and 100 cc of cloudy synovial fluid was aspirated. The knee was then injected with a mixture of 4cc 1% lidocaine, 4cc 0. 25% marcaine and triamcinolone acetonide (kenalog) 80mg. The patient tolerated the procedure well; post injection instructions were given. Plan: continue icing, nonsteroidal anti-inflammatory drugs and activity modification. Follow up in two weeks. The patient understands she would notify our office if symptoms worsen or if she becomes afebrile. On (b)(6) 2017, the patient presented for follow up. The problem was located at the right knee and left knee. The patient's chief complaint was eval bilateral knees. It was reported that the patient had continued pain, morning stiffness, pain with standing/sitting long periods, pain with walking long periods; recurrent swelling. The patient tried and failed icing, aleve, physical therapy (pt), sleeve brace (cuts off circulation). Had done both cortisone and viscosupplementaion (visco synvisc helped, last series early (b)(6) 2017 but resulted in flare up on 4th injection of series, cortisone injections with aspiration again yesterday by the doctor). Cortisone, yesterday's injection continued to provide good pain relief. No instability. Referred by the doctor for eval for total knee arthroplasty (tka). Recently had bl knee mris done ordered by the doctor. Still was very active, walks 6 miles a day twice a week. Has had modify activities however in that she can no longer run, dance, other activities she enjoys. The patient was being seen for follow up knee/hip. She was experiencing swelling, weakness, tenderness, stiffness and instability. The severity of the problem is (b)(6) 2010. She was here as the result of an injury. The injury was not work related. The patient had seen a physician in the past for this problem. The injury was caused by other (long term use). She described the pain as aching, exhausting, miserable, nagging, penetrating, sharp, shooting, tender, throbbing and tiring. The problem was worsening. The following were modifying factors: worsened with walking/activity, improved with rest, worsened with climbing stairs, worsened with descending stairs, improved with medication (takes edge off but not completely -aleve) and worsened with sleeping. The context of the problem was a previous injury. The onset of the problem was after exercise, with activity, over a period of time and other (all the time). She has recently experienced night sweats, nausea, heartburn, swelling lower extremities, muscle weakness, stiffness and joint pain. It was reported that varus arthritis x-ray performed- bilateral standing ap, lateral, and sky views of the right and left knee taken demonstrate medial joint space narrowing with marginal osteophyte formation, periarticular sclerosis and cysts bilaterally. Physical exam:- inspection/palpation; diffuse global tenderness-right knee; effusion-right knee; medial joint line tenderness-right knee-left knee; lateral joint line tenderness-right knee; peripatellar pain-right knee-left knee; peripatellar crepitation-right knee-left knee. The patient appears healthy, well developed, well nourished and well groomed. The patient appears able to communicate well and appropriate to the situation. On (b)(6) 2018, the patient presented follow-up of her bilateral knee osteoarthritis. It was reported that the patient had bilateral synvisc-one injections that were complicated by acute inflammatory reaction requiring aspiration and injection. Her left knee settled down, but she was having some persistent pain and swelling in her right knee. The lot of synvisc she received was the one that was compromised with contaminant. We had notified her of this as well as sending her a letter denying a fracture. She was here today for follow-up of her right knee. She denied any fevers or chills. She complained primarily some pain and persistent swelling in the right knee. Her left knee was doing much better. Physical examination: musculoskeletal: right knee showed moderate effusion. She had no erythema, warmth or signs of infection. She had some stiffness secondary to swelling. Mild diffuse joint line pain as well as patellofemoral irritability. No calf pain or swelling. Negative homans1 sign, mildly antalgic gait. The plan included: after discussion with the patient regarding treatment options, a mutual decision was made to proceed with an aspiration/injection of the right knee joint. The right knee was sterilely prepped, and 30 cc of blood tinged clear synovial fluid. Fluid sent for routine studies including gram stain, cell count, crystals, protein, glucose, anaerobic and aerobic, afb and fungal cultures. The knee was then injected with a mixture of 4cc 1% lidocaine, 4cc 0. 25% marcaine and triamcinolone acetonide 80mg. The patient tolerated the procedure well; post injection instructions were given. No obvious signs of infection based on fluid aspirate. Reassured the patient that i do not see any acute need for surgical intervention. A follow-up in two to three weeks or sooner was scheduled should swelling persist or worsen. The patient also aware to look for signs of infection such as fever, redness, increasing pain, etc. If any of these develop, she would notify immediately. It was reported that they would wait before doing tka. Would give more time from psuedoseptic reaction from synvisc one. May wish to try euflexxa or orthovisc. To get in pool and swim, all questions answered, eventual tka when cant to it anymore. Action taken: no action taken. Corrective treatment: triamcinolone acetonide, icing, aleve, bracing with patellar sleeve brace for acute inflammatory reaction/psuedoseptic reaction; triamcinolone acetonide for flare up; not reported for other events outcome: unknown for all events. 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 (b)(6) 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. Seriousness criteria: required intervention and disability for device malfunction and acute inflammatory reaction/psuedoseptic reaction; required intervention for flare up.
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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 Key7583225
MDR Text Key110569973
Report Number2246315-2018-00486
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 Other Health Care Professional
Remedial Action Recall
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 Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/08/2018 Patient Sequence Number: 1