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Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Arthralgia (2355); Reaction, Injection Site (2442); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 11/10/2017
Event Type  malfunction  
Event Description
Based on additional information received on (b)(6) 2018, this case initially considered as non-serious was upgraded to serious: [event of device malfunction with seriousness criteria important medical event was added]. This unsolicited case from united states was received on (b)(6) 2017 from the other health care professional. This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after unknown latency the patient experienced left knee pain (latency: unknown) and inability to walk/cannot walk (after 1 day), was having some problems (after 28 days) and corticosteroid injection given with synvisc one; also, device malfunction was identified for the reported lot number. The patient has a history of lt knee fracture in the 1990. In the last 3-4 years the knee has been painful. Medical history was significant for pulmonary disease: copd, high cholesterol, diabetes, surgical history: basal cell skin cancer upper lip. The patient was allergic to erythromycin (had headache). Type 2 diabetes mellitus without complication, pure hypercholesterolemia, hyperlipidemia, obesity, recurrent major depression, dysthymia, depressive disorder, chronic depression, essential hypertension, acute upper respiratory infection, pneumonia, chronic bronchitis, chronic obstructive lung disease, alopecia areata, osteoarthritis, osteoarthritis of knee, knee pain, foot pain, right, epigastric pain, abnormal glucose level, metatarsal bone fracture, contusion of lower limb, postmenopausal state, adult health examination, depression (including post partum), surgical history included cancer - basal cell skin cancer removed from upper lip (b)(6) 2017, orthopedic surgery - tibial plateau fracture, laparoscopy (b)(6) 1995, c-section (b)(6). Patient had osteoarthritis of the knee. The patient has a varus deformity of the knee with palpable osteophytes. The patient was retired, widowed, former smoker, non-smoker, smoking - former smokers - quit time: 6 -10 years since last cigarette, alcohol intake: occasional, chewing tobacco: none. Concomitant medication included fluticasone propionate/salmeterol xinafoate (advair), salbutamol sulfate (albuterol sulfate), citalopram, fluticasone, diclofenac sodium (diclofenac), lidocaine, lisinopril, lovastatin, metformin hydrochloride (metformin), salbutamol sulfate (proair hfa), theophylline. The patient's father died at age (b)(6) years. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the 6 ml once (batch/lot number: 7rsl021; expiration date: 31-may-2020) for oa knee pain in the left knee. The patient was there for lt knee pain. The patient was requesting a synvisc one injection into the knee. No recent imaging. In the last 3-4 years the knee has been painful. The pain was occasional and depends on the day. The patient's vitals were blood pressure 126/70 sitting left arm pain scale was 4. The patent had left knee x-rays done. The patient had osteoarthritis of knee, unilateral primary osteoarthritis, left knee. After discussion of the risks and benefits, the patient elected to proceed with a cortisone injection into the left knee. Confirmed that the patient did not have history of prior adverse reactions, active infections, or relevant allergies. There was no effusion, erythema, or warmth, and the skin was clear. The skin was sterilized with alcohol. Topical anesthesia was achieved with ethyl chloride. A 22 gauge needle was inserted into the joint via a lateral approach. The site was injected with synvisc one and cc 1% lidocaine. The injection was completed without complication, and a bandage was applied. The patient tolerated the procedure well and was instructed to avoid strenuous activity for the next 24-48 hours and to use ice, nsaids, or tylenol for pain as needed. The patient will call immediately with any signs of infection or allergic reaction. The patient will return as needed. The patient also received lidocaine 10 mg/ml (1 %) injection solution-take 5 ml by injection route. Administered batch/lot number lot #: 73032dk route: injection site: left knee exp date: 01/01/2019 administer qty: 5 ml. The left, views (x-ray, knee): ap, lateral and sunrise, there was a varus deformity of the knee there is severe narrowing of the medial joint compartment. On the same day, x-ray showed varus deformity, sever narrowing of medical. On (b)(6) 2017, the patient called complaining of severe left knee pain and an inability to walk/cannot walk (event onset date: (b)(6) 2017; latency: unknown). Patient was instructed to ice, rest, elevate and take ibuprofen as necessary. On (b)(6) 2017, the patient was called back and was still complaining of pain. The appointment was set for (b)(6) 2017. Unfortunately, the patient never showed up for the office visit on (b)(6) 2017 and the office had been unable to speak to her despite multiple attempts. The patient called into office on (b)(6) 2017 at 09:34 and stated that she received injection synvisc one and reported that she was unable to walk. On (b)(6) 2017, the patient stated that she was still in pain and would like to talk to nurse about it. On (b)(6) 2017, it was reported that the patient had some problems. Corrective treatment: ice, rest, elevate and take ibuprofen for both; not reported for rest of events outcome: not recovered for left knee pain/still in pain; unknown for inability to walk/cannot walk, was having some problems. A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(5) 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. Seriousness criterion: important medical event for device malfunction follow up was received on (b)(6) 2018. No new information was received. Additional information was received on (b)(6) 2018. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly. Additional information was received on (b)(6) 2018 from a healthcare professional. The patient's medical history and concomitant medication, past drugs were added. The suspect drug's batch/lot number was updated. Additional events of device malfunction, corticosteroid injection given with synvisc one, was having some problems were added along with details. The event term of left knee pain was updated to left knee pain/still in pain; the event term of inability to walk was updated to inability to walk/cannot walk. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who suffered from inability to walk, left knee pain, device use issue and some unspecified problems after receiving synvisc one injection from the recalled lot. Temporal relationship can be established between the events (except for unspecified problems and device use issue) and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company. Therefore, pharmacological plausibility of the events to the product cannot be excluded (except for unspecified problems and device use issue).
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater, NJ 08807
MDR Report Key7288235
MDR Text Key101132331
Report Number2246315-2018-00327
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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,Followup
Report Date 11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2018
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: 02/22/2018 Patient Sequence Number: 1