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

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ

  • 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
 

GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Cyst(s) (1800); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Date 11/07/2017
Event Type  Injury  
Event Description
Based on additional information received on (b)(6) 2018, this case initially considered non serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added. This unsolicited case from united states was received on (b)(6) 2017 from other non health care professional this case concerns a (b)(6) female patient who received treatment with synvisc one injection and after few hours wasn't able to move leg, wasn't able to walk for weeks, had severe pain, took lots of fluid out of knee, could not bend knee, could not do any workout and after unknown latency experienced an adverse reaction. Also device malfunction was identified for the reported lot number. No past drug, concomitant medication and concurrent condition was provided. The patient had history of meniscus issue (for which doctor recommended that gel shot). The patient had no allergy. On (b)(6) 2017, the patient received treatment with intra- articular synvisc one injection (batch/lot number: 7rsl021, expiration date, dose, frequency: not provided) to lubricate knee. The same day, 2 hours after the patient got that shot, she wasn't able to move leg and had severe pain which ended up going to the hospital for two days. They took lots of fluid out of patient's knee and wasn't able to walk for two weeks. It was reported that more than a month the patient used a walker to get around t and was still in pain. The patient received treatment with hydrocodone-acetoin 7. 5 and meloxicam 15 mg just for pain. On (b)(6) 2017, the patient saw the healthcare professional. She visited the emergency room and was admitted on the same day. On (b)(6) 2017, the patient was discharged. On an unknown date, after unknown latency experienced an adverse reaction. It was reported that the patient could not take any of those product (synvisc one) anymore and still had pain. The patient could not bend knee, could not sit on the floor and was not able to do any workout which she was able to do. Corrective treatment: walker for wasn't able to move my leg, wasn't able to walk for weeks; celecoxib (200 mg 1 capsule), ciprofloxacin (500 mg twice a day), hydrocodone acetaminophen (1 tablet a day) and meloxicam (15 mg; 1 tablet a day) for severe pain; not reported for other events outcome: unknown for experienced an adverse reaction; not recovered for rest of 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 was under investigation. Once this investigation would be completed, corrective and preventive actions would be implemented seriousness criteria: hospitalization/prolongation for: device malfunction, wasn't able to move my leg, wasn't able to walk for weeks and severe pain additional information was received on (b)(6) 2018. Global ptc number and ptc results added. Text amended accordingly. Additional information was received on (b)(6) 2018 from the patient. This case initially considered non serious was upgraded to serious as the serious events of device malfunction, wasn't able to move my leg, wasn't able to walk for weeks, severe pain with seriousness criteria as hospitalization/prolongation were added. Also the event of can't bend knee, can't do any workout was added. The suspect product indication, batch/lot number and start date was added. The history of meniscus issue was added. Clinical course updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 15-march-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was hospitalized due to being unable to walk, having knee pain and knee effusion. 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

Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7373654
MDR Text Key103947306
Report Number2246315-2018-00415
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
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 Received03/15/2018
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: 03/27/2018 Patient Sequence Number: 1
-
-