• 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 Problem Microbial Contamination of Device (2303)
Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 11/11/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]. Patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight [weight bearing difficulty]. Pain terminally straightening the knees and bending the knees beyond 90 degrees [aching (r) knee]. Patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight [joint stiffness]. 3+effusion of bilateral knees/aspirated [effusion (r) knee]. Knees are warm [joint warmth]. Case narrative: the case is cross-referenced to (b)(4) (multiple devices). Initial information received on 07-oct-2019 regarding an unsolicited valid legal serious case from united states received from a non-healthcare professional (lawyer). This case involves a (b)(6) years old male patient who, experienced patient's knees started to become stiff and then progressively worse to the point where he was unable to bear weight (latency same day), knees are warm, pain terminally straightening the knees and bending the knees beyond 90 degrees, 3+effusion of bilateral knees/aspirated (latency 1 day) while he started treatment with medical device hylan g-f 20, sodium hyaluronate (synvisc one). Also reported lot number was identified to have malfunction by the company (device malfunction). The patient's past medical history included right knee effusion, knee pain/pain in the medial aspect of left knee/pain in the anterior medial aspect of his right knee/increased pain after walk, complaints to his right wrist/soreness on valor aspect of wrist/pain worsened in wrist (pain was aching and stabbing in nature, moderate in intensity), right wrist injury ((b)(6) 2015), right wrist was 1+ soft tissue swelling, limping since onset of left medial knee pain, nighttime symptoms that keep him from sleeping restfully, pain with sitting and stair climbing/problems with stair climbing and kneeling as well as squatting and describes it as aching sensation due to which patient was unable to run, meniscus tear of left knee/meniscus tear of right knee, right knee arthroscopy and partial medial meniscectomy of right knee ((b)(6) 2010), swelling in the right knee/increased swelling after walk, gout which affected his left foot at (b)(6) 2009, patellofemoral syndrome, chondromalacia of the medial femoral condyle, right knee, ongoing osteoarthritis of both knees. The patient's family history included lung cancer. Patient had no known drug allergies. The patient's past medical treatments included synvisc one injections and past vaccination(s) was not provided. On (b)(6) 2017, the patient received hylan g-f 20, sodium hyaluronate (synvisc one) in right knee (dosage: unknown) via intra-articular route, once, (batch number: 7rsl021; expiration date: unknown) for osteoarthritis. On (b)(6) 2017, when he got home from the injections, in the night, patient's knees started to become stiff (assessed serious as required intervention) and then progressively worse to the point where he was unable to bear weight (caused disability) (latency: same day). On (b)(6) 2017, 1 day later, patient came in wheelchair, complaining of agony in his knees. He was having pain terminally strengthening the knees and bending the knees beyond 90 degrees (assessed serious as required intervention) (1 day later). His knees were warm but no erythema or signs of infection and he also denied calf pain. He was neurovascularly intact distally. It was thought that he was having reaction to the synvisc one. On same day, (after latency of 1 day) he was aspirated with 30 ml of fluid from right knee, and then injected with 80 mg of depo-medrol and 2 ml of 1% lidocaine via same portal. The patient tolerated the aspiration injection well. Patient was then placed in compression stockings and was prescribed for indomethacin 50 mg, which he was going to take for the next 2 to 3 days and was going for follow up with physician as scheduled. He would continue with cold therapy and modified activity. Action taken: not applicable for all events. Corrective treatment: steroids (dopo-medrol) for knees started to become stiff and then progressively worse to the point where he was unable to bear weight, pain terminally straightening the knees and bending the knees beyond 90 degrees, 3+effusion of bilateral knees/aspirated, device malfunction; wheelchair for knees started to become stiff and then progressively worse to the point where he was unable to bear weight, device malfunction; not reported for knees are warm. Outcome: unknown for all the events. A pharmaceutical technical complaint was initiated for synvisc one (lot number: 7rsl021) with global ptc number (unknown). 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 is completed, corrective and preventive actions would be implemented.
 
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 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key9217654
MDR Text Key169728354
Report Number2246315-2019-00264
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Remedial Action Recall
Type of Report Initial
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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: 10/22/2019 Patient Sequence Number: 1
-
-