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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Joint Swelling (2356); No Code Available (3191)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
Based on information received on 31-jan-2018, the report previously considered as non-valid became valid and from non-serious to serious as new serious events of device malfunction, knee swelling and aspirated in er /aspirate done were added with seriousness criteria of required intervention. (b)(4). This unsolicited case from united states was received on 22-dec-2017 from a healthcare professional. This case concerns an adult (b)(6) male patient who received treatment with synvisc one and after unknown latency the patient experienced knee swelling; after a latency of 1 week patient knee was aspirated in er /aspirate done and gram staining was with moderate wbc, no organism. Also, device malfunction was identified for the reported lot number. No past drug, concomitant medication, medical history or concurrent condition was provided. On (b)(6) 2017, the patient initiated treatment with single intra-articular synvisc one injection at a dose of 1 df once for acute knee pain (batch/ lot number: 7rsl021 and expiration date: 31-may-2020). On an unknown date in (b)(6) 2017, latency unknown, patient had knee swelling. On (b)(6) 2017 after a latency of 1 week patient's knee was aspirated in er. The fluid was sent for culture which came out to be negative and gram staining was done with moderate wbc and no organisms. Patient was treated with medrol dose pack. Corrective treatment: methylprednisolone (medrol) for knee swelling and aspirated in er /aspirate done; not reported for other events. Outcome: not recovered for gram stain with moderate wbc, no organism; unknown for other 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 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. Additional information was received on 31-jan-2018 from the patient. Events of device malfunction, knee swelling, aspirated in er /aspirate done and gram staining with moderate wbc, no organism. Event of adverse reaction (unevaluable event) was deleted. Clinical course was updated and text amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 31-jan-2018: this case concerns a male patient who had received synvisc- one injection from re-called lot and later developed right knee swelling and effusion and had moderate wbc's in the synovial fluid the temporal relationship is significant and hence, causal role of suspect product cannot be ruled out in occurrence of the event. Furthermore, the concerned lot has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products 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 Key7279775
MDR Text Key100555608
Report Number2246315-2018-00315
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 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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 Received01/31/2018
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: 02/19/2018 Patient Sequence Number: 1