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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (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 Fatigue (1849); Muscle Weakness (1967); Weakness (2145); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 26-mar-2018 from consumer. This case concerns a (b)(6) female patient who received treatment with synvisc one and later after unknown few hours patient limped off the table, some pain in her left knee/pain got worse during that afternoon and night, some swelling/more swelling on her left knee the next day/left knee swollen upto twice size, knee was hot to touch. Also, device malfunction was identified for the reported lot number. No past drugs and concomitant medication was provided. Patient had a history of diabetes mellitus type i and osteoarthritis. On an unknown date in 2017 ((b)(6) 2017 or (b)(6) 2017, she did not know the exact date she had the injection), the patient initiated treatment with intra-articular synvisc one injection once in left knee at a dose of 6 ml for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown). On an unknown date in 2017, few hours after receiving synvisc one, the patient limped off the table and did experiences some pain in her left knee. She said when she got home she her pain got worse during that afternoon and night. She said she was experiencing some swelling that same night but there was more swelling in her left knee the next day. She said the knee was hot to the touch and swollen. It was further reported that her left knee swollen up twice size mainly inner side of her left knee. Patient was able to bear weight before and after injection. She said the physician told her to stay off the knee for a couple of days. She said she had a crutch to help walk around at home. She said she called the physician's office the next day and talked to the nurse. She said the nurse told her that was normal to have pain after the injection and told her to start taking ibuprofen for the pain. She said the pain increased and so did the swelling. She said she had to go to physician therapy for two months and was given ice and electrical stimulation to her left knee. She said as of today, the knees still had some pain but not as much and the knee would get inflamed some if she did not exercise the knee and walk. She said she does knee stretches to help with the knee pain and swelling. She said she is still recovering but she still has some pain. Corrective treatment: crutches, electro therapy, physiotherapy, knee stretches for limped off the table; ibuprofen for some pain in her left knee/pain got worse during that afternoon and night; ice for some swelling/more swelling on her left knee the next day/left knee swollen upto twice size and knee was hot to touch outcome: not recovered for limped off the table, device malfunction; recovering for rest of the events a pharmaceutical technical complaint (ptc) was initiated with (b)(4). 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: disability for limped off the table; important medical event for device malfunction. Additional information was received on 29-mar-2018. Global ptc number was added. Text amended accordingly. Pharmacovigilance comment: sanofi follow-up company comment dated 29-mar-2018. The follow-up information received does not alter the overall case assessment. This case concerns a patient who received treatment with synvisc one from the recall lot and later experienced pain, swelling, joint warmth and difficulty in walking for which patient had to use crutches. Since event occurred on the day of administration of synvisc one injection, significant temporal relationship can be established and causal role of suspect product cannot be denied in occurrence of the events. Furthermore, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the product to the events cannot be excluded.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7431555
MDR Text Key106144372
Report Number2246315-2018-00448
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
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2018
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 Received03/26/2018
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: 04/14/2018 Patient Sequence Number: 1
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