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Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Fatigue (1849); Fever (1858); Urinary Retention (2119); Myalgia (2238); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 12/13/2017
Event Type  Injury  
Event Description
Difficulty walking [walking difficulty], cannot walk [walking disability], urinary retention [urinary retention], device malfunction [device malfunction], redness [application site joint redness], stiffness [joint stiffness], fever [fever], insomnia [insomnia], fatigue [fatigue], decreased libido [libido decreased], urinary urgency [urinary urgency], decreased range of motion/ trouble flexing past 90 degree [joint range of motion decreased], muscle weakness [muscle weakness], muscle pain [muscle pain], weakness [weakness], loss of balance [balance difficulty], memory loss [memory loss], bilateral pseudoseptic reaction [pseudosepsis] ([joint warmth], [knee swelling], [knee pain], [knee effusion]), right knee baker's cyst [baker's cyst], synovial fluid red blood cells positive [synovial fluid red blood cells positive], synovial fluid white blood cells positive [synovial fluid white blood cells positive], significant pain while standing or walking [pain upon movement] ([condition worsened]). Case narrative: initial information received on 12-sep-2018 regarding an unsolicited valid serious malfunction case from united sates received from healthcare professional. This case involves a (b)(6) male patient (172. 7 cm and (b)(6)) who experienced significant pain while standing or walking (latency: same day), stiffness (latency: 1 day), fever, insomnia, fatigue, decreased libido, urinary retention, urinary urgency, decreased range of motion/ trouble flexing past 90 degree, muscle weakness, muscle pain, weakness, loss of balance, difficulty walking, memory loss, bilateral pseudoseptic reaction, right knee baker's cyst, synovial fluid red blood cells positive, synovial fluid white blood cells positive (latencies: 2 days) and cannot walk (latency: 1 day), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history included acl repair, bilateral medial compartment knee osteoarthritis, pacemaker insertion, knee surgery, cardiac surgery, non-smoker and abstains from alcohol. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included terazosin hcl. On (b)(6) 2017, the patient was administered synvisc one bilaterally (hylan g-f 20, sodium hyaluronate), intra-articular injection, 6 ml dosage, 1x (lot - 7rsl021) for bilateral primary osteoarthritis. On (b)(6) 2017, procedure of bilateral knee viscosupplementation injection was performed in ultrasound guidance. The skin was cleaned with chloraprep. The skin overlying the target was anesthetized with 3 ml of 1% lidocaine using a 22 gauge, 1-1/2 inch needle under direct ultrasound visualization, using a lateral to medial in-plane approach on the right and medial to lateral on the left. The syringe was then exchanged for a 6 ml vial of synvisc-one and this was injected under direct ultrasound guidance without difficulty on each side. The patient tolerated the procedure well without complication. He was instructed to ice the knee as needed and f/u in 3 months. Later in the evening after the injections he experienced significant pain, redness, warmth and swelling in the bilateral knees. Also, he had significant pain with standing or walking. He was using crutches from home to assist with ambulations and had not gone to work in the past 2 days due to pain. Current pain score reported was 7/10. On (b)(6) 2017, physician spoke to the patient and assured him that ibuprofen and acetaminophen were fine to use pain control and he could also use his biotin massage cream to the posterior knee as reported. On (b)(6) 2017, patient's findings included bilateral knee pain, fever, insomnia, fatigue, decreased libido,urinary retention, urinary urgency, joint swelling, joint stiffness, muscle weakness, decreased range of motion, muscle pain, weakness, loss of balance, difficulty walking, memory loss. Palpation during knee examination indicated popliteal fossa tenderness, right knee warmth, lateral knee tenderness, medial knee tenderness, lateral joint line tenderness, medial joint line tenderness, anterior knee tenderness, prepatellar swelling, medial patella tenderness, lateral patella tenderness and popliteal cyst in the right knee. Palpation of the left knee indicated posterior tenderness, warmth, prepatellar tenderness, tenderness under the medial facet of the patella and tenderness under the lateral facet of the patella. Bilateral-pseudoseptic reaction was associated with viscosupplementation. On (b)(6) 2017, bilateral knees were aspirated and labs were sent for evaluation of synovial fluid including infectious markers and crystal analysis. Longer acting anesthetic was instilled into the knee joints bilaterally to provide therapeutic pain relief. Patient was advised to use ice and non-steroidal anti inflammatories for pain. On (b)(6) 2017, large joint arthrocentesis procedure was performed for both the knees. Patient was prepped and draped in usual sterile fashion. Eighteen g needle was used and superolateral approach was used during the procedure. Three ml lidocaine was used during the procedure and 15 ml of fluid was aspirated from left knee and 25 ml was aspirated from the right knee and fluid was sent for laboratory analysis. The left knee aspirated fluid was cloudy, yellow and blood-tinged whereas the right knee aspirated fluid was yellow and cloudy. Patient tolerated the procedure well with no immediate complications. Right knee baker's cyst arthrocentesis with ultrasound guidance was performed. A popliteal cyst was noted in the right knee. The patient was placed prone and the popliteal fossa was examined and the baker's cyst was identified. The area was prepped with chloraprep in the usual sterile fashion. A 25 g needle was then used to infiltrate 3 ml of 1% lidocaine subcutaneously until the cyst was entered. The needle was then withdrawn and a 19 g 1. 5 inch needle was placed under direct ultrasound guidance. The cyst was fenestrated and aspirated, with multiple passes and while the leg was milked, until the above amount of fluid was returned. The needle was then removed and pressure applied. No bleeding or other complications were noted and (b)(6) was placed. The patient tolerated the procedure well and reported significant pain relief afterwards. On (b)(6) 2017, lab results were high wbcs in synovial fluid (9575 in left knee, 16950 in left knee) and high red blood cells in synovial fluid (15100 in left knee, 775 in right knee). Final diagnosis was significant pain while standing , cannot walk, stiffness, synovial fluid white blood cells positive, synovial fluid red blood cells positive, right knee baker's cyst, memory loss, difficulty walking, loss of balance, weakness, muscle pain, muscle weakness, decreased range of motion/ trouble flexing past 90 degree, urinary urgency, urinary retention, decreased libido, fatigue, insomnia, fever and bilateral pseudoseptic reaction. The patient was treated with ibuprofen for arthralgia, diclofenac for arthralgia, acetaminophen for arthralgia and biotin. Outcome: recovering for significant pain while standing or walking, stiffness; unknown for rest of the events. Seriousness criteria: disability for walking disability and gait disturbance; medically significant for urinary retention. 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 received on 17-sep-2018 from healthcare professional. Updated for symptom pain at score of 10 and above to pain at score of 10 and above/bilateral knee pain. Clinical course updated. Text amended accordingly.
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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 Key7905729
MDR Text Key121606141
Report Number2246315-2018-00583
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 health professional
Remedial Action Recall
Type of Report Initial
Report Date 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
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
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: 09/25/2018 Patient Sequence Number: 1