• 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 Arthritis (1723); Bacterial Infection (1735); Fatigue (1849); Nausea (1970); Therapeutic Response, Decreased (2271); Discomfort (2330); Joint Disorder (2373); No Code Available (3191)
Event Date 11/07/2017
Event Type  Injury  
Event Description
This spontaneous case from united states was received on 23-jan-2018 from patient's husband. This case concerns a (b)(6) female patient who initiated treatment with synvisc one and after a few hours had inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now, couldn't move/couldn't get around the edge of the bed, was unable to bend the right knee/couldn't put weight on it, was screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth, had right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen, was unable to straighten out her right leg/can't straighten it/ couldn't straighten my leg; on the same day had to drag my foot when i walked with a walker, also, device malfunction was identified for the reported lot number. No medical history, previous medications, concomitant medications and concurrent conditions were reported. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 10 ml (frequency: not provided) for osteoarthritis and torn meniscus (batch/ lot number: 7rsl021 and expiry date: unknown). On the same day, after a few hours, patient was screaming with pain, inability to walk, unable to straighten out her right leg, right knee had swelling the size of a baseball, unable to bend the right knee. During the first week first week she used ice, elevation, slept in a low bed, and used a walker to go to the bathroom. Patient's hcp prescribed 600-800 motrin, elevation, ice, and she was wearing a molded knee brace. Patient reported that no circumference measurements had been taken of the right knee, she was unable to bare weight or walk after this injection, and had pain level of 10 after this injection, denied fever, had blood work but was not sure for what, turned wrong this weekend and hurt her knee, had not recovered from this injection. Action taken: unknown. Corrective treatment: molded knee brace, wheel chair for inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now, couldn't move/couldn't get around the edge of the bed; ice for unable to bend the right knee/couldn't put weight on it and unable to straighten out her right leg/can't straighten it/couldn't straighten my leg; ice, elevation, ibuprofen (motrin) for screaming" with pain/hurt her knee/worst pain/in pain/had pain on the knee back and forth, right knee had swelling "the size of a baseball/knee was like a softball/ it swelled up/swollen. Outcome: not recovered for all events. Seriousness criteria: disability for device malfunction and inability to walk/unable to walk after this injection/couldn't walk/walk with my leg bent now. 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. Pharmacovigilance comment: sanofi company comment dated 28-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later was unable to walk and mobility decreased. 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 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7250644
MDR Text Key99841756
Report Number2246315-2018-00229
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
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
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
-
-