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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); Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Reaction, Injection Site (2442); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Event Description
This spontaneous case from united states was received on 22-dec-2017 and 23-dec-2017 (processed with clock start date of 22-dec-2017) from the patient.This case concerns a patient (demographics: not provided) who initiated treatment with synvisc one and after an unknown latency was couldn't walk, couldn't bend leg, had pain and swelling, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose: not provided) for osteoarthritis.On an unknown date in 2017, after an unknown latency patient couldn't walk, couldn't bend leg had pain and swelling.Patient experienced extreme pain and swelling for many days.It had been 3.5 weeks since patient received the injection in my right knee and still had pain and swelling.Corrective treatment: cane; knee brace for couldn't walk; advil; knee brace for pain; not reported for others.Outcome: recovered for couldn't walk, couldn't bend leg; recovering for pain; not recovered for rest.Seriousness criteria: disability for couldn't walk and device malfunction.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.Pharmacovigilance comment: sanofi company comment dated 22-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced inability to walk, joint range of motion decreased, knee pain and swelling.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunctioned by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
 
Event Description
This spontaneous case from united states was received on 22-dec-2017 and 23-dec-2017 (processed with clock start date of 22-dec-2017) from the patient this case concerns a patient (demographics: not provided) who initiated treatment with synvisc one and after an unknown latency was couldn't walk, couldn't bend leg, painful as hips, had pain and swelling; also, device malfunction was identified for the reported lot number.No previous medications were reported.Patient had no medical history.Concomitant medications include ibuprofen (advil), ezetimibe/simvastatin (vytorin) for high low density lipoprotein (ldl) and naproxen sodium (aleve) to reduce swelling, on (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose and expiration date: not provided; lot number: 7rsl021) for osteoarthritis.The same day, the patient couldn't walk, couldn't bend leg had pain and swelling (latency: 8 hours).Patient experienced extreme pain and swelling for many days.Patient could not walk for three days and walking required use of a cane afterwards.X-ray showed bone on bone in inner right knee.It had been 3.5 weeks since patient received the injection in my right knee and still had pain and swelling.On (b)(6) 2017, the patient had fluid drawn.Corrective treatment: cane; knee brace for couldn't walk; advil, knee brace and sulfamethoxazole/trimethoprim for pain; sulfamethoxazole/trimethoprim (smz-tmp ds) for painful as hips and swelling; not reported for others outcome: recovered for couldn't bend leg; recovering for swelling and pain/extreme pain; not recovered for rest seriousness criteria: disability for couldn't walk and device malfunction 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 will be implemented.Additional information was received on 12-jan-2018 form the patient.Concomitant medications were added.An additional event of painful as hips was added with details.Event onset date was updated for couldn't walk, had pain and swelling.Event outcome of couldn't walk was updated.Event outcome was upadted for the event of pain/extreme pain.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 22-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced inability to walk, joint range of motion decreased, knee pain and swelling.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunctioned by the company.Therefore, the causal relationship of the events to the products cannot be excluded.
 
Event Description
Device malfunction [device malfunction] couldn't walk [unable to walk] synovial fluid appearance cloudy [synovial fluid analysis abnormal] white count of 1400 with only 45% neutrophils [synovial fluid white blood cells positive] synovial fluid color bloody [synovial fluid color] discomfort in left knee [discomfort in joints] couldn't bend leg [joint range of motion decreased] painful as hips [pain in hip] right knee pain/extreme pain [pain in knee] right knee swelling [swelling of r knee] right knee aspiration [effusion (r) knee] case narrative: this spontaneous case from united states was received on (b)(6) 2017 and (b)(6) 2017 (processed with clock start date of (b)(6) 2017) from the patient this case concerns a male patient of 66 years who initiated treatment with synvisc one and after an unknown latency was couldn't walk, couldn't bend leg, painful as hips, had pain and swelling, right knee aspiration, synovial fluid color bloody, synovial fluid appearance cloudy, discomfort in left knee, white count of 1400 with only 45% neutrophils; also, device malfunction was identified for the reported lot number.Patient had no medical history included drug hypersensitivity, hypercholesterolaemia, overweight, musculoskeletal stiffness, arthralgia, joint complaint (right knee), rhinitis allergic, sinus congestion, nasal disorder, upper-airway cough syndrome, sinusitis, tinnitus, erythema, oedema, renal cyst and diverticulitis.Patient's surgical history included tonsillectomy.Patient's family history included cardiac disorder with father, diabetes with mother and hypertension.Patient consumed alcohol, consumed marijuana, was a former smoker (till (b)(6) 1992), abstained from recreational drugs at the time of this report.Previous medications included aspirin (acetylsalicylic acid), ibuprofen and naproxen.Concomitant medications include ibuprofen (advil), ezetimibe/simvastatin (vytorin) for high low density lipoprotein (ldl), naproxen sodium (aleve) to reduce swelling and mefenamic acid (mefenamic acid).On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose and expiration date: not provided; lot number: 7rsl021) for degenerative arthritis.The same day, the patient couldn't walk, couldn't bend leg had pain and swelling (latency: 8 hours).Patient experienced extreme pain and swelling for many days.Patient could not walk for three days and walking required use of a cane afterwards.X-ray showed bone on bone in inner right knee.It had been 3.5 weeks since patient received the injection in my right knee and still had pain and swelling.On (b)(6) 2017, the patient had fluid drawn out of knee.The cultures were negative.On (b)(6) 2017, the aspirate showed a white count of 1400 with only 45% neutrophils, synovial fluid color bloody and synovial fluid appearance cloudy.It was also reported that the patient had bone-on-bone degenerative arthritic changes in the medial compartment.Because of the continued exacerbation of his pain, it was thought to appropriate to bring him in for aspiration of his knee and institution of antibiotics because of the synvisc one recall.The patient had had full extension, flexion to about 110 degrees that have pain along the medial joint line.He had mild joint effusion as a +1 effusion.The same day about 4 cc of somewhat bloody minimally viscous fluid that was sent for culture and sensitivity, aerobic and anaerobic as well as cell count.The patient was started on bactrim ds one tablet twice daily.The patient experienced discomfort in left knee probably from overcompensating for the pain in his right knee.Pain seemed better after voltaren gel.On (b)(6) 2018, the patient received another synvisc one injection in his knee.No further information was provided.Corrective treatment: cane; knee brace for couldn't walk; advil, knee brace, voltaren gel and sulfamethoxazole/trimethoprim for pain; sulfamethoxazole/trimethoprim (smz-tmp ds) for painful as hips and swelling; bactrim ds for knee aspirate; not reported for others outcome: recovered for couldn't bend leg; recovering for swelling and pain/extreme pain; unknown for knee aspirate, white count of 1400 with only 45% neutrophils, synovial fluid color bloody and synovial fluid appearance cloudy; not recovered for rest seriousness criteria: disability for couldn't walk and device malfunction a pharmaceutical technical complaint (ptc) was initiated with 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 will be implemented.Additional information was received on (b)(6) 2018 form the patient.Concomitant medications were added.An additional event of painful as hips was added with details.Event onset date was updated for couldn't walk, had pain and swelling.Event outcome of couldn't walk was updated.Event outcome was updated for the event of pain/extreme pain.Clinical course was updated and text was amended accordingly.Follow up information was received on (b)(6) 2018.Global ptc number was added.Text was amended accordingly.Additional information was received on (b)(6) 2018.New events of discomfort in left knee, knee aspirate, white count of 1400 with only 45% neutrophils, synovial fluid color bloody and synovial fluid appearance cloudy were added with details.Medical history of drug hypersensitivity, hypercholesterolaemia, overweight, musculoskeletal stiffness, arthralgia, joint complaint (right knee), rhinitis allergic, sinus congestion, nasal disorder, upper-airway cough syndrome, sinusitis, tinnitus, erythema, oedema, renal cyst and diverticulitis, surgical history of tonsillectomy and family history of cardiac disorder with father, diabetes with mother and hypertension were added.Suspect drug indication was updated to degenerative arthritis.Patient demographics were received and updated.Clinical course was updated, and text was amended accordingly.
 
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Brand Name
SYNVISC ONE
Type of Device
INTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7189701
MDR Text Key98010241
Report Number2246315-2017-00593
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/22/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/15/2018
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 Received01/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADVIL(CON.)-START; ADVIL(CON.)-START; ADVIL(CON.)-STOP UNKNOWN; ALEVE (NAPROXEN SODIUM),UNKNOWN; ALEVE(CON.) - START; ALEVE(CON.) - STOP UNKNOWN; MEFENAMIC ACID (MEFENAMIC ACID),UNKNOWN; VYTORIN (EZETIMIBE, SIMVASTATIN),UNKNOWN; VYTORIN(CON.) - START UNKNOWN (ONGOING)
Patient Outcome(s) Disability;
Patient Age65 YR
Patient Weight124
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