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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 Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)
Event Type  malfunction  
Event Description
Based on information received on 24-apr-2018, the report previously considered as non-valid became valid as the additional events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added.Additionally, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction was added).This unsolicited case from united states was received on 23-jan-2018 from patient.This case concerns a (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency, could not bend, severe pain in knee/ pain significantly worse after reaction and had significant swelling in knee and also had issue on long term basis since receiving synvisc-one.Additionally, the device malfunction was reported for the lot number used.No previous medications, medical history, concomitant medications and concurrent conditions were reported.It was reported that the patient was allergic to penicillin.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for osteoarthritis (batch/ lot number: 7rsl021 and expiry date: unknown).Patient had been experiencing issue on long term basis since receiving synvisc one.On unknown dates, the patient experienced severe pain and significant swelling in the knee and the patient could not bend it.The patient reported that the pain was significantly worse after the injection than prior to the injection.On (b)(6) 2017 and (b)(6) 2018, the patient consulted the health professional.At the time of report on (b)(6) 2018, the patient still had these problems.Corrective treatment: not reported for all the events outcome: not recovered for all events a product technical complaint 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: important medical event for device malfunction.Additional information was received on 07-feb-2018.Investigation summary results and global ptc number were added.Clinical course was updated and text was amended accordingly.Additional information was received on 24-apr-2018 from the patient.The patient's date of birth, age and height were added.The events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added along with the details.Clinical course was updated and text was amended accordingly.
 
Event Description
Device malfunction [device malfunction].Could not bend [mobility decreased] many white blood cells in joint fluid, left knee [synovial fluid white blood cells positive] severe pain in knee/ pain significantly worse after reaction [knee pain] significant swelling in knee [knee swelling] issue on long term basis since receiving synvisc-one [unevaluable event] case narrative: based on information received on 24-apr-2018, the report previously considered as non-valid became valid as the additional events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added.Additionally, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction was added).This unsolicited case from united states was received on 23-jan-2018 from patient.This case concerns a 56 years old female patient who initiated treatment with synvisc one and after an unknown latency, could not bend, severe pain in knee/ pain significantly worse after reaction and had significant swelling in knee and also had issue on long term basis and after 24 days had many white blood cells in joint fluid, left knee since receiving synvisc-one.Additionally, the device malfunction was reported for the lot number used.Patient has past medical history of diverticulitis, diverticulitis of colon, essential hypertension, benign high blood pressure, hypothyroid, other psoriasis and transient ischemic attack.Previous medications include ascorbic acid, b complex, oscal, losartan and multivitamin.Concomitant medication include atorvastatin, synthroid, liothyronine and lorcaserin hcl.It was reported that the patient was allergic to penicillin, erythromycin and budeprion xi.Past surgery included ankle arthoscopy/surgery, breast biopsy, cesarean section and knee surgery.Family history included that her father had suffered from nonmelanoma skin cancer, diabetes, arrhythmia, arthritis and diverticulosis.Her mother had experienced diverticulosis and arthritis.Her child experienced allergies and psoriasis.She is a non-smoker and consume alcohol.On (b)(6) 2017 patient received treatment with intra articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/ lot number: 7rsl021 and expiry date: unknown).Patient had been experiencing issue on long term basis since receiving synvisc one.On unknown dates, the patient experienced severe pain and significant swelling in the knee and the patient could not bend it.The patient reported that the pain was significantly worse after the injection than prior to the injection.On (b)(6) 2017 laboratory test revealed many white blood cells in joint fluid of left knee (latency: 24 days) and patient consulted healthcare professional.On (b)(6) 2017 there were many white blood cells in joint fluid of left knee.On (b)(6) 2017 , laboratory test revealed many white blood cells in joint fluid of left knee.On (b)(6) 2018, the patient consulted the health professional.At the time of report on (b)(6) 2018, the patient still had these problems.Corrective treatment: not reported for all the events.Outcome: recovering for severe pain in knee/ pain significantly worse after reaction; unknown for many white blood cells in joint fluid, left knee; not recovered for rest of the events.A product technical complaint was initiated with global ptc number (b)(4).A product technical complaint (ptc) was initiated on 07-feb-2018 for synvisc one.Batch number: 7rsl021, global 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 is completed, corrective and preventive actions would be implemented.Seriousness criteria: medically significant for device malfunction.Additional information was received on 07-feb-2018.Investigation summary results and global ptc number were added.Clinical course was updated and text was amended accordingly.Additional information was received on 24-apr-2018 from the patient.The patient's date of birth, age and height were added.The events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added along with the details.Clinical course was updated and text was amended accordingly.Follow up information was received on 08-may-2018.No new information received additional information received on 16-jul-2018 from healthcare professional.Past medical history, past surgical history, family history and concomitant medication was added.Outcome of severe pain in knee/ pain significantly worse after reaction was updated to recovering from not recovered.Text amended accordingly.Follow-up information received on 02-aug-2018 from healthcare professional.No new information was added.Follow-up information received on 21-aug-2018 from healthcare professional.No new information was added.Additional information was received on 10-sep-2018 from healthcare professional.Event of many white blood cells in joint fluid, left knee was added with details.Clinical course updated.Text amended accordingly.
 
Manufacturer Narrative
Sanofi company comment dated 10-sep-2018: follow-up information received does not change the prior assessment.This case concerns a patient who has received synvisc one injection from the recalled lot and later could not bend, had severe pain in knee/ pain significantly worse after reaction and significant swelling in knee.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 product cannot be excluded.
 
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Brand Name
SYNVISC ONE
Type of Device
MOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7487586
MDR Text Key107384676
Report Number2246315-2018-00471
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
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
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATORVASTATIN [ATORVASTATIN CALCIUM] (ATORVASTATIN; LIOTHYRONINE (LIOTHYRONINE),; LORCASERIN HYDROCHLORIDE (LORCASERIN HYDROCHLORIDE; SYNTHROID (LEVOTHYROXINE SODIUM),
Patient Outcome(s) Other;
Patient Age56 YR
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