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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problem No Code Available (3191)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
This case has been cross referred with case (b)(4) (cluster). This unsolicited case from united states was received on (b)(6) 2018 from a patient. This case concerns (b)(6) year old female patient who received treatment with synvisc one injection and after unknown latency the patient experienced foot swollen, whole leg was swollen and red, could not walk, leg is getting weak, sick, cannot kneel at all, whole leg was swollen and red and knee throbs at night, feels like a needle, knee pain/pain level of 5 out of 10 before the shot and 9-10 after the shot/knee throbs at night, removed fluid from knee and it swells more than her other knee does. Also, device malfunction was identified for the reported lot number. It was reported that the patient received cortisone shot in her knee on an unknown date in (b)(6) 2017, but she had not had previous synvisc one injections. Also, the patient had a pain level of 5 out of 10 before the shot. The patient was told by her doctor before the injection that the bones in her knee were rubbing together and she could either have the shot or have surgery. The patient decided to have surgery, but the doctor recommended the synvisc one first. The patient had no known allergies besides seasonal hay fever allergies. She did not have diabetes or any prosthetic joints or devices. Patient's concurrent condition included high blood pressure and is treated by four unspecified medications. On (b)(6) 2017 at about 02: 00 pm, the patient received treatment with intra-articular synvisc one injection once (dose and indication: not provided) (lot number 7rsl021 and expiration date: unknown). It was reported that the patient went to work until 6:00pm. On the same day, the patient's foot was already swollen at 6:00pm and when she got home her whole leg was swollen and red. She used pain pills and ice all weekend and went to the doctor on monday, but she did not have an appointment, so she had to go home and come back on tuesday for a prescription for stronger pain pills. On an unknown date, after unknown latency, the patient experienced the tremendous swelling and pain and she could not walk. She was unable to work for ten days and she used a walker for two weeks and was still using a cane now. Reportedly, patient had a pain 9-10 after the shot and she was still taking unspecified pain pills. Also, reported that the patient's knee throbbed at night, felt like a needle and it swelled more than her other knee does and she could not kneel at all. It was reported that the patient did not wanted to lose her leg and she was afraid her bones might be deteriorating, she felt like her leg was getting weak. The doctor had recommended physical therapy. Also, reported that her doctor had given her three different pain pills and she was concerned that they may affect her kidney or liver. On an unknown date in (b)(6) 2018, few months after receiving synvisc one injection, the doctor removed fluid from the knee, but it did not help the pain. The patient had an ultrasound to rule out blood clots and there were no blood clots. The patient also had bloodwork done and the doctor said it was not good. Further reported that the patient's blood work was not too bad and she had to repeat bloodwork seven to ten days ago. The results of the same were unknown at this time. Corrective treatment: unspecified medication and ice for pain; ice for whole leg was swollen and red and walker and cane for could not walk. Outcome: not recovered/ not resolved for all the events. A pharmaceutical technical complaint (ptc) was initiated and the results were pending. Seriousness criteria: disability for the event of device malfunction and could not walk. 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. Pharmacovigilance comment: sanofi follow-up company comment dated: (b)(6) 2018: this case concerns a female patient who received treatment with synvisc one from the recalled lot and later had knee pain, knee swelling, swelling of legs, sick, cannot walk, redness, cannot kneel at all. Based upon the company investigation, the causal role of the product cannot be denied with the occurrence of event. Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors would aid in the complete medical assessment of the case.
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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 Key7331061
MDR Text Key102448645
Report Number2246315-2018-00371
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 consumer
Reporter Occupation Patient
Remedial Action Recall
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2018
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: 03/12/2018 Patient Sequence Number: 1