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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 Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Type  Injury  
Event Description
Device malfunction [device malfunction]. Pain/dull pain/"throbing" pain/moderate tenderness/grinding pain [knee pain] ([throbbing pain], [discomfort in joints]). Knee joint has a small effusion/left knee effusion [effusion (l) knee]. Range of motion was slightly decreased [joint range of motion decreased]. Mild intraarticular crepitance [joint crepitation]. Lot of swelling [swelling of l knee]. Stiffness [joint stiffness]. Case narrative: initial unsolicited information of serious legal case received from united states on 14-jan-2019 from a lawyer. This case involves a (b)(6) female patient who experienced pain/dull pain/throbbing pain/moderate tenderness/grinding pain, knee joint has a small effusion/left knee effusion, lot of swelling, stiffness, range of motion was slightly decreased and mild intraarticular crepitance with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). Additionally, event of device malfunction was added for the identified recall lot. The patient was allergic to asa. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included amlodipine; probiotics nos; ranitidine; pantoprazole; zafirlukast; azelastine; mometasone furoate (nasonex); hydrocodone bitartrate, paracetamol; plantago ovata (metamucil [plantago ovata]); zafirlukast (accolate); vitamin d3; loratadine; bifidobacterium infantis (align); macrogol 3350 (miralax); levalbuterol hcl; gabapentin; vitamin b12; levosalbutamol hydrochloride (xopenex); umeclidinium bromide, vilanterol trifenatate (anoro ellipta); levothyroxine and budesonide. On (b)(6) 2017, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage 6ml once (batch: 7rsl021) for unilateral primary left knee osteoarthritis. The affected knee was prepped with betadine followed by alcohol swab and then synvisc one visco-supplementation injection was administered. The patient tolerated the procedure well with no complications. On (b)(6) 2017, patient reported for follow up for her bilateral knee pain. Patient reported since an unknown date after the injection, she was having a lot of swelling (latency: unknown) and throbbing in that knee (latency: unknown). Further, she described her pain as grinding pain, dull pain. She also had stiffness (latency: unknown) and she discomfort at night in her left knee. The patient rated her pain as 8/10 and 10/10 and it was located along the medial joint line. The symptoms were gradual in onset. Upon examination, her left knee joint had a small effusion (latency: unknown) and mild intraarticular crepitance (latency: unknown) was also noted. The mcmurrays test caused pain at medial joint line and her range of motion was slightly decreased (latency: unknown). The same day, left knee aspiration was performed. Patient was advised that the effusion and pain are likely related to the inflammatory response to the injection. The patient's knee was prepped with betadine followed by alcohol swab and 5cc of marcaine was injected, followed by aspiration of 30 ml normal appearing joint fluid, followed by a depo medrol injection of 5ml. The patient tolerate the procedure well. On 17-jan-2018, patient was contacted to notify regarding the recall lot injection she had received. On (b)(6) 2018, patient reported again for her follow up and was administered a corticosteroid injection for her knee pain and left knee effusion. The left knee was prepped with betadine followed by alcohol swab and 5cc of marcaine was injected followed with 5ml of marcaine containing 40mg depo medrol. Patient was instructed to follow up if she had any of her symptoms recur. Corrective treatment: marcaine, depo medrol for pain/dull pain/throbbing pain/moderate tenderness/grinding pain, knee joint has a small effusion/left knee effusion. Outcome: unknown for all events. Seriousness criterion: intervention required for pain/dull pain/throbbing pain/moderate tenderness/grinding pain, knee joint has a small effusion/left knee effusion and device malfunction. An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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.
 
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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
MDR Report Key8270292
MDR Text Key133845753
Report Number2246315-2019-00025
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
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
Is the Reporter a Health Professional?
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: 01/23/2019 Patient Sequence Number: 1
Treatment
ACCOLATE (ZAFIRLUKAST),UNKNOWN; ALIGN (BIFIDOBACTERIUM INFANTIS),UNKNOWN; AMLODIPINE (AMLODIPINE),UNKNOWN; ANORO ELLIPTA,UNKNOWN; AZELASTINE (AZELASTINE),UNKNOWN; BUDESONIDE (BUDESONIDE),UNKNOWN; GABAPENTIN (GABAPENTIN),UNKNOWN; HYDROCODONE BITARTRATE AND ACETAMINOPHEN,UNKNOWN; LEVALBUTEROL HCL (LEVALBUTEROL HCL),UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LORATADINE (LORATADINE),UNKNOWN; METAMUCIL [PLANTAGO OVATA] (PLANTAGO OVATA),UNKNOW; MIRALAX (MACROGOL 3350),UNKNOWN; NASONEX (MOMETASONE FUROATE),UNKNOWN; PANTOPRAZOLE (PANTOPRAZOLE),UNKNOWN; PROBIOTICS NOS (PROBIOTICS NOS),UNKNOWN; RANITIDINE (RANITIDINE),UNKNOWN; VITAMIN B12 [VITAMIN B12 NOS],UNKNOWN; VITAMIN D3 (VITAMIN D3),UNKNOWN; XOPENEX (LEVOSALBUTAMOL HYDROCHLORIDE),UNKNOWN; ZAFIRLUKAST (ZAFIRLUKAST),UNKNOWN
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