• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Headache (1880); Nausea (1970); Pain (1994); Swelling (2091); Dizziness (2194); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Date 11/17/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on (b)(6) 2018 from patient this case concerns a (b)(6) year old female patient who received treatment with synvisc one and after few hours of receiving injection leg was sore, knee was red, unable to stand the evening after the injection, knee was warm, knee was swollen 5&1/2 inches bigger than her left knee/swelling, soreness behind her knee; after unknown latency could not walk from excruciating pain, could not move her leg and was dizzy. Also, device malfunction was identified for the reported lot number. No concomitant medications was reported. Patient been having synvisc or synvisc one injections for six or seven years. Patient had the series of three synvisc injections until two years ago, then synvisc. Patient has had injections in both her knees in the past. The patient had synvisc one injections in both knees in (b)(6) 2016. Patient left knee was done again in (b)(6) 2017, but her right knee was fine at the time so she did not have it done then. Before the injection her pain level was 7 out of 10. The patient has no prosthetic joint or device, she had cortisone shots in her shoulder for her rotator cuff, but no other immune suppressant therapy. Patient has no allergies to avian products or eggs. Patient has no diabetes or other chronic diseases. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (lot number: 7rsl021; dose, frequency, indication and expiration date: not reported) in right knee. Patient stated that the procedure went great, she hopped down off the table and went about her day. Patient did not jog or exercise the knee, she just went about her day. On the same day, after few hours of receiving injection, after lunch her leg was sore. Patient knee would be tender sometimes after the third of three synvisc injections, but not like this. It was reported that the swelling started by dinner time the same day. The knee was red, warm and she had soreness behind her knee. Patient did not thought she had a fever. On an unknown date in (b)(6) 2017, latency unknown, later that friday night, patient could not walk from excruciating pain, her knee was swollen 5&1/2 inches bigger than her left knee and patient went to her emergency room (er). The er doctor called the on call orthopedic doctor who told him not to aspirate the knee. Ice and morphine was recommended, but the morphine did not even touch the pain. No bloodwork was done and no fluid was removed from the knee. Patient was not admitted to the hospital. On sunday morning, she called the orthopedic doctor on call because she was still in pain and could not move her leg without physically picking it up and moving it. Patient took oxycodone and was very dizzy, but was able to start moving her toes, ankles and leg. After she was able to start moving the leg, the swelling started to get better. On wednesday, patient went back to the orthopedic doctor and they gave her a cortisone shot in the knee. It got worse for about 12 hours, then calmed down. After the injection, it was more than 10 out of 10. The patient was able to bear weight before the injection, but was unable to stand the evening after the injection. Patient used a walker, then a wheelchair to get around. The patient was doing pretty good now, but her right knee was sorer than the left, even though the left was usually the bad one in the past. Patient could not use her right leg first while going down stairs now. The patient has been very happy with synvisc and synvisc one in the past and has recommended it to friends. Action taken: unknown corrective treatment: ice, morphine, cortisone shot, oxycodone for leg was sore, could not move her leg, soreness behind her knee; ice, morphine, cortisone shot for knee was red, knee was swollen 5&1/2 inches bigger than her left knee/swelling, knee was warm, could not walk from excruciating pain; walker, wheelchair for unable to stand the evening after the injection; not reported for rest events. Outcome: recovering for all the 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. Seriousness criteria: required intervention for leg was sore, device malfunction, knee was red, knee was warm, knee was swollen 5&1/2 inches bigger than her left knee/swelling and soreness behind her knee; disability for unable to stand the evening after the injection, could not walk from excruciating pain, could not move her leg. Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced leg pain, localized erythema, unable to walk, mobility decreased and difficulty in standing for which patient received cortisone shot. A temporal relationship can be established with the product administration. Furthermore, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7240419
MDR Text Key99784127
Report Number2246315-2018-00195
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 Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2018
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/05/2018 Patient Sequence Number: 1