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U.S. Department of Health and Human Services

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

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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 11/15/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction], antalgic gait [antalgic gait], swelling [swelling of r knee], warmth to knee [joint warmth], large effusion [effusion (r) knee], pain with knot at the knee [knee pain]. Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request. This case is cross referenced with cases: (b)(4) (cluster). This unsolicited case was received on 05-jan-2018 from a pharmacist via health authority of united states (usfda with regulatory reference number: mw5073939). This case involves a patient of unknown demographics age who received treatment with synvisc one and later after one day had swelling, warmth to knee, pain with knot at the knee; after unknown latency had large effusion and antalgic gait. Also, device malfunction was identified for the reported lot number. No medical history, past drugs, concomitant medications or concurrent condition was provided. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at dose of 6 ml once (batch number: 7rsl021 and expiration date: 31- may-2020) for osteoarthritis of knee. On (b)(6) 2017, one day after receiving injection, patient reported: continued pain with "knot" at the knee. Patient was recommended rest, ice, and otc (over the counter) pain medications (tylenol/ibuprofen). It was reported that patient had worsening symptoms: swelling and warmth to knee. Patient follow up visit scheduled at clinic. On an unknown date, latency unknown, doctor noted: markedly antalgic gait, large effusion, and mild warmth of right knee. It was reported that the 85 ml of cloudy fluid aspirated and patient received injection of 3ml of 1 percent lidocaine and 80 mg of methylprednisolone. Patient reported improved symptoms. On follow up visit, patient improved with plans to proceed with right total knee arthroplasty. Corrective treatment: rest, ice, tylenol/ibuprofen, lidocaine, methylprednisolone for pain with knot at the knee; 85ml of cloudy fluid aspirated, lidocaine, methylprednisolone for large effusion and swelling; lidocaine, methylprednisolone for warmth to knee; 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: medically significant for antalgic gait, swelling, warmth to knee, large effusion, pain with knot at the knee; required intervention for swelling, warmth to knee, large effusion, pain with knot at the knee. Pharmacovigilance comment: sanofi company comment dated 30-jan-2018: this case concerns a patient who received right intra-articular synvisc one injection from the recalled lot and had antalgic gait later with increased knee pain, swelling, effusion and warmth. 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.
 
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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 Key7233973
MDR Text Key213219729
Report Number2246315-2018-00250
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
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: 02/01/2018 Patient Sequence Number: 1
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