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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373)
Event Date 11/29/2017
Event Type  malfunction  
Event Description
This case is cross referred with the cases: (b)(4) (cluster), (b)(4) (duplicate). This unsolicited case from united states was received on 13-feb-2018 from a health care professional. This case concerns a (b)(6) male patient who received treatment with synvisc one injection and after few hours had difficulty with weight bearing/unable to weight bear, had extreme pain, swelling/immediate swelling; after unknown latency had right knee aspirated/120 cc aspirated and after 2 days had cloudy synovial fluid. Also device malfunction was identified for the reported lot number. Concomitant medication included testosterone and human chorionic gonadotropin. No past drugs. Medical history, concurrent conditions were reported. On (b)(6) 2017, at 7:55 am, patient received treatment with intra- articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: may-2020) for right knee osteoarthritis. On the same day (at 3:30 pm), few hours after receiving injection, patient had extreme pain, swelling/immediate swelling, difficulty with weight bearing. On the same day, patient had ice, nsaids, elevation, ibuprofen (600 mg three times daily). On an unknown date in (b)(6) 2017, after unknown latency, right knee aspirated/ 120 cc aspirated. On (b)(6) 2017, on office visit patient had clear to cloudy synovial fluid. It was reported that knee was injected with 4 cc 1% lidocaine/0. 25% marcaine and 80 mg triamcinolone acetonide. On (b)(6) 2018, at office visit it was reported that events have resolved but the knee was till painful. Corrective treatment: triamcinolone acetonide (kenalog), ice, elevation, ibuprofen, nsaids for difficulty with weight bearing/unable to weight bear, extreme pain, swelling/immediate swelling; aspiration, kenolog for right knee aspirated/120 cc aspirated; not reported for rest events outcome: unknown for device malfunction and cloudy synovial fluid; not recovered for extreme pain; recovered for rest events. Reporter causality description: related for immediate swelling, pain, unable to weight bear 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. Seriousness criteria: required intervention for device malfunction, difficulty with weight bearing/unable to weight bear, extreme pain, swelling/immediate swelling, right knee aspirated/120 cc aspirated pharmacovigilance comment: sanofi company comment dated 22-feb-2018: this case concerns a patient who suffered from weight bearing difficulty, synovial fluid analysis abnormal, right knee pain, swelling of right knee, and effusion (r) knee after receiving synvisc one injection from the recalled lot. Temporal relationship can be established between the events 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.
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Manufacturer (Section D)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
bridgewater, NJ 08807
MDR Report Key7311998
MDR Text Key101713853
Report Number2246315-2018-00340
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
Remedial Action Recall
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2020
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 Received02/13/2018
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: 03/03/2018 Patient Sequence Number: 1