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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303); Contamination of Device Ingredient or Reagent (2901); Device Contamination With Biological Material (2908)
Patient Problems Arthritis (1723); Erythema (1840); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); Ambulation Difficulties (2544); Fluid Discharge (2686); No Code Available (3191)
Event Date 11/22/2017
Event Type  Injury  
Event Description
Based on additional information received on 05-feb- 2018, this case became medically confirmed (from health care professional). Based on additional information received on 06-dec- 2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime). This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on 06-dec-2017 from a non-healthcare professional. This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion, difficulty bearing weight, difficulty ambulating, stiffness, pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion. Also device malfunction was identified for the reported lot number. Concomitant medications include olmesartan medoxomil (benicar), fish oil and ergocalciferol (vitamin d). Patient had bilateral knee osteoarthritis, cancer, stroke, hypertension, degenerative disc disease lumbar. Patient had drug allergy- progesterone and sulfonamide on (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis/bilateral knee osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020). On (b)(6) 2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating. The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee. It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees. Corrective treatment: 70cc drained from left knee and 50cc from right knee for bilateral drainage performed/knee effusion and swelling/swollen; not reported for rest of the events. Outcome: recovered for pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion; unknown for rest events. Reporter causality description: yes for swollen and painful knee after synvisc one. A pharmaceutical technical complaint (ptc) was initiated with ptc number: (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 was under investigation. Once this investigation would be completed, corrective and preventive actions would be implemented. Seriousness criteria: device malfunction as important medical event. Additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of 06-dec-2017). This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime). The global ptc number with ptc result was added. Clinical course updated. Text amended accordingly. Additional information was received on 05-feb-2018 from health care professional. This case became medically confirmed. Verbatim was updated for the event of bilateral drainage performed too bilateral drainage performed/knee effusion; pain to pain/increased pain/painful knee; swelling to swelling/swollen. Outcome was updated for the events of pain/increased pain/painful knee, swelling/swollen and bilateral drainage performed/knee effusion from unknown to recovered. Clinical course updated. Text amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 05 - feb - 18. The follow received does not change the previous assessment of the case. This case concerns a patient who has received synvisc one injection from the recalled lot and later experiencejoint range of mition decreased, weight bearing difficulty and difficulty walking. 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.
 
Event Description
Based on additional information received on 06-dec- 2017, this case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime). This case is cross referenced with case: (b)(4) (cluster). This unsolicited case from united states was received on 06-dec-2017 from a non-healthcare professional. This case concerns a (b)(6) year old female patient who received treatment with synvisc one and later 1 day after receiving treatment had decreased range of motion, difficulty bearing weight, difficulty ambulating, stiffness, pain, swelling and bilateral drainage performed. Also device malfunction was identified for the reported lot number. No past drug, medical history, concomitant medication or concurrent condition was provided. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (bilateral injection) into the knees for osteoarthritis (batch/lot number: 7rsl021; expiry date: 31-may-2020). On (b)(6) 2017, (1 day after receiving synvisc one injection), the patient she returned with pain, swelling, stiffness, decreased range of motion, difficulty bearing weight and ambulating. The same day, a bilateral drainage was performed and 70cc was drained from left knee and 50cc from right knee. It was reported that the patient was told to take over the counter (otc) pain medicines and ice the knees. Action taken: unknown corrective treatment: 70cc drained from left knee and 50cc from right knee for bilateral drainage performed and swelling; not reported for rest of the events. Outcome: unknown for all the events a pharmaceutical technical complaint (ptc) was initiated with ptc number: 50914 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 would be completed, corrective and preventive actions would be implemented. Seriousness criteria: device malfunction as important medical event. Additional information was received on 06-dec-2017 and 29-dec-2017 (both processed together with the clock start date of (b)(6) 2017). This case initially considered non-serious was upgraded to serious as the serious event of device malfunction was added with seriousness criteria as important medical event (ime). The global ptc number with ptc result was added. Clinical course updated. Text amended accordingly. Pharmacovigilance comment: sanofi company comment follow up dated 6-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experience joint range of mition decreased, weight bearing difficulty and difficulty walking. 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 DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7186452
MDR Text Key284972093
Report Number2246315-2018-00116
Device Sequence Number0
Product Code MOZ
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/08/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/12/2018 Patient Sequence Number: 1
Treatment
BENICAR (OLMESARTAN MEDOXOMIL),UNKNOWN; BENICAR (OLMESARTAN MEDOXOMIL),UNKNOWN; BENICAR (OLMESARTAN MEDOXOMIL),UNKNOWN; BENICAR(CON.); BENICAR(CON.); ERGOCALCIFEROL (ERGOCALCIFEROL),UNKNOWN; ERGOCALCIFEROL (ERGOCALCIFEROL),UNKNOWN; ERGOCALCIFEROL (ERGOCALCIFEROL),UNKNOWN; FISH OIL (FISH OIL),UNKNOWN; FISH OIL (FISH OIL),UNKNOWN; FISH OIL (FISH OIL),UNKNOWN; FISH OIL(CON.); FISH OIL(CON.); PROGESTERONE(PREV.); PROGESTERONE(PREV.); VITAMIN D(CON.); VITAMIN D(CON.)
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