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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Hypoesthesia (2352); Arthralgia (2355); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Sanofi company follow up comment dated 23-jan-2019:follow up information does not change previous case assessment. This case concerns a patient who was on treatment with hylan g-f 20, sodium hyaluronate (synvisc) and required intervention for joint noise, arthralgia and knee effusion. There is no evidence of the event to occur with device. Therefore, the role of device cannot be established. Further, detailed information regarding clinical course of the events would aid in better assessment of the case.
 
Event Description
2+ crepitus with popping [joint crepitation]. Tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing [joint tenderness] ([condition aggravated]). 1+ effusion [effusion (r) knee]. Slipped and fell [fall]. Decreased sensation along the lateral aspect of the leg and dorsum of the foot [numbness in leg]. Case narrative: initial information received on 17-jan-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "(b)(6)". Patient id: (b)(6); country: united states. Study title: sanofi patient connection. This case involves a (b)(6) years old male patient who had treatment with hylan g-f 20, sodium hyaluronate (synvisc) and after unknown latency experienced 2+ crepitus with popping, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and slipped and fell, 1+ effusion, decreased sensation along the lateral aspect of the leg and dorsum of the foot. The patient's past medical history included post right partial medial and lateral meniscectomy, post chondroplasty right patella and excision patella fracture fragment, debridement right acl tear and partial synovectomy, post lateral retinacular release. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing varicose vein in knee (bilateral right greater than left) and wears support hose, was a knee brace user and right medial compartment osteoarthritis. Concomitant medications included chondroitin sulfate, glucosamine sulfate (glucosamine chondroitin sulfate). On an unknown date in 2017, the patient started taking hylan g-f 20, sodium hyaluronate intra-articular injection once x 3 weeks (with an unknown batch number) for unknown indication. On (b)(6) 2018, patient slipped and fell at work, sent to auc, seen and released. On (b)(6) 2018, patient complained that pain was 1 out of 10 and was interested in a steroid injection. Patient claimed that the hylan g-f 20, sodium hyaluronate really helped. Patient stated that the knee brace had worn out and he was wearing support hose for the varicose veins. Patient said that currently the pain was worse at night. Right knee exam showed active range of motion of 0-125, incision were healed well. Patient had 1+ effusion, had no medial or lateral; instability at zero or 30 but had pain on valgus stressing, 1+ anterior drawer, tender along medial joint line, 2+ crepitus with popping and media facet tenderness, negative homans test, decreased sensation along the lateral aspect of the leg and dorsum of the foot. The patient had good distal pulses and no new skin lesions. The patient was given a steroid injection, given a new knee brace as old one was worn out. Patient was recommended neurontin and to repeat hylan g-f 20, sodium hyaluronate injections. Final diagnosis was slipped and fell, tender along medial joint line/media facet tenderness/recurrent right knee pain and 2+ crepitus with popping. Action taken: unknown. Corrective treatment: methylprednisolone acetate (depomedrol) and ice for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping, not reported for rest. Outcome: unknown for all events. Seriousness criteria: intervention required for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping. Reporter causality: unassessable (unknown) for all events. Company causality: not reportable for all events. A product technical complaint was initiated on (b)(6) 2019 for synvisc. Batch number: unknown global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review is not possible. Based on lack of information provided, no capa is required. It was the requirement to review all finished batch records for specification conformation prior to release. Any out of specification result is identified and mitigated through the ncr process. Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals. This review did not indicate any safety issue. Sanofi would continue to monitor adverse events to determine if a capa was required. Additional information received on 23-jan-2019. Investigation summary received and ptc results added. Clinical course updated. Text amended accordingly.
 
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Brand NameSYNVISC
Type of DeviceMOZ
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 Key8291166
MDR Text Key134568922
Report Number2246315-2019-00033
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,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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: 01/30/2019 Patient Sequence Number: 1
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