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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problem Arthritis (1723)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
This case is cross referred to (b)(4) (cluster). This unsolicited case from united states was received on 21-feb-2018 from a medical doctor and nurse. This case concerns a (b)(6) female patient who experienced septic arthritis/ infection of left knee (unknown latency), elevated wbc at 13. 3 (02 days later), esr elevated at 85 (02 days later) and crp elevated at 24. 7 (02 days later) after receiving treatment with synvisc one. Also device malfunction was identified for the reported lot number. Medical history included hypertension. Concurrent condition included chronic pain syndrome. Concomitant medications reported include tramadol hydrochloride (tramadol) for chronic pain, gabapentin for neuropathic pain, indometacin (indomethacin) for arthritis. The patient was allergic to oxycodone hydrochloride/ paracetamol (percocet) and codeine (vomiting/itching/ nausea) and tetanus toxoid (anaphylaxis). On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection 1 df once (batch/ lot number: 7rsl021, expiry date: not provided) for severe knee arthralgia injected to each knee. The same day, the patient experienced increased pain, stiffness, swelling and heat to the injected knee on left side. On (b)(6) 2017, the patient was taken to the o. R. By orthopedics for washout. The same day, white blood cell count was elevated 13. 3, esr (erythrocyte sedimentation rate) was elevated 85, c-reactive protein was elevated 24. 7 (units and reference range not provided) for all and the blood culture showed no growth. On an unspecified date in (b)(6) 2017 after unknown latency, the patient experienced septic arthritis/ infection of left knee. Corrective treatment: vancomycin, linezolid, piperacillin sodium/tazobactam sodium (zosyn), ciprofloxacin (cipro) and ceftriaxone sodium (rocephin) for septic arthritis/ infection of left knee; not reported for rest all the events outcome: not recovered for device malfunction and septic arthritis/ infection of left knee; unknown for rest 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 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 would be completed, corrective and preventive actions would be implemented. Seriousness criteria: important medical event for device malfunction and septic arthritis/ infection of left knee reporter causality: yes for septic arthritis/ infection of left knee. Pharmacovigilance comment: sanofi company comment dated 02-mar-2018: this case concerns a patient who received treatment with synvisc one injection from the recalled lot and later experienced septic arthritis, knee pain, joint stiffness, knee swelling, joint warmth, knee effusion, wbc increased, esr increased and crp increased. 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 Key7326944
MDR Text Key102318894
Report Number2246315-2018-00363
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 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
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? No
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/09/2018 Patient Sequence Number: 1