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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); Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)
Event Type  malfunction  
Event Description
This spontaneous case from united states was received on 09-feb-2018 from patient.This case concerns (b)(6) female patient who initiated treatment with synvisc one and after unknown latency patient walked on tread mill before synvisc-one injections, not after recalled injections, right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain before recalled injections almost the same but not quite, measured her left knee after recalled injection and it was 1" larger/both feet are slightly puffy.Also device malfunction was noted for the reported lot number.No previous medications, concomitant medications and concurrent conditions were reported.Patient had a pacemaker.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once bilateral for arthritis (batch/ lot number: 7rsl021 and expiry date: unknown).Consumer's right knee hurt after the injection, the left knee felt better for the first 24 hours, then both knees hurt worse each day down to the shin bone.Consumer didn't want to stand up or walk on her legs due to the pain, and husband pulls her up out of a chair.Consumer walked on tread mill before synvisc-one injections, not after recalled injections; she measured her left knee after recalled injection and it was 1" larger.Consumer denied swelling or redness of the right knee, both feet are slightly puffy.Consumer was weight bearing before recalled injections and weight bearing when necessary after recalled injections.Consumer denied using support devices before or after recalled injections.Consumer used diclofenac sodium topical gel 1% a dozen times a day and every hour at night for pain.Patient reported that she had not recovered and had constant pain.She denied fever, lab work, hospitalization.Consumer had taken a few aspirin for pain after injections.Corrective treatment: diclofenac sodium topical gel 1%, aspirin for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain before recalled injections almost the same but not quite; not reported for other outcome: not recovered for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain before recalled injections almost the same but not quite and device malfunction; unknown for other events.Seriousness criteria: important medical event for 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 15-feb-2018: this case concerns a female patient who received treatment with a recalled lot of synvisc one and experienced decreased mobility, swelling if limbs and knee pain.The role of the device cannot be denied for the occurrence of the event based upon the available information.Further the concerned lot number has been identified to have malfunction.Therefore, the causal role of the device in the development of events cannot be denied.
 
Event Description
This spontaneous case from united states was received on (b)(6) 2018 from patient.This case concerns 80 years old female patient who initiated treatment with synvisc one and after unknown latency patient walked on tread mill before synvisc-one injections, not after recalled injections, right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees, measured her left knee after recalled injection and it was 1" larger/both feet are slightly puffy, injection did not work (device ineffective).Also device malfunction was noted for the reported lot number.No previous medications, concomitant medications and concurrent conditions were reported.Patient had a pacemaker.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once bilateral for arthritis (batch/ lot number: 7rsl021 and expiry date: unknown).Consumer's right knee hurt after the injection, the left knee felt better for the first 24 hours, then both knees hurt worse each day down to the shin bone.Consumer didn't want to stand up or walk on her legs due to the pain, and husband pulls her up out of a chair.Consumer walked on tread mill before synvisc-one injections, not after recalled injections; she measured her left knee after recalled injection and it was 1" larger.Consumer denied swelling or redness of the right knee, both feet are slightly puffy.Consumer was weight bearing before recalled injections and weight bearing when necessary after recalled injections.Consumer denied using support devices before or after recalled injections.Consumer used diclofenac sodium topical gel 1% a dozen times a day and every hour at night for pain.Patient reported that she had not recovered and had constant pain.She denied fever, lab work, hospitalization.Consumer had taken a few aspirin for pain after injections.It was reported that the injection did not work, pain was still in knees and blood work done was normal corrective treatment: diclofenac sodium topical gel 1%, aspirin for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees; not reported for other events outcome: not recovered for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees and device malfunction; unknown for other events (except for injection did not work ) seriousness criteria: important medical event for 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.Additional information was received on 08-mar-2018 from the patient.Event term was updated from right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain to right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees.Additional event of injection did not work was added along with details.Clinical course was updated.Text was amendedaccordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 08-mar-2018: the follow up information received does not change the previous case assessment.This case concerns a female patient who received treatment with a recalled lot of synvisc one and experienced decreased mobility, swelling if limbs and knee pain.The role of the device cannot be denied for the occurrence of the event based upon the available information.Further the concerned lot number has been identified to have malfunction.Therefore, the causal role of the device in the development of events cannot be denied.
 
Event Description
This spontaneous case from united states was received on 09-feb-2018 from patient.This case concerns 80 years old female patient who initiated treatment with synvisc one and after unknown latency patient walked on tread mill before synvisc-one injections, not after recalled injections, right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees, measured her left knee after recalled injection and it was 1" larger/both feet are slightly puffy, injection did not work (device ineffective).Also device malfunction was noted for the reported lot number.No previous medications, concomitant medications and concurrent conditions were reported.Patient had a pacemaker.On (b)(6) 2017, patient requested for synvisc one injection.On an unknown date in 2017, patient received treatment with intra articular synvisc one injection once bilateral for arthritis (batch/ lot number: 7rsl021 and expiry date: unknown).It was reported that as of (b)(6) 2017, the injection did not work.Consumer's right knee hurt after the injection, the left knee felt better for the first 24 hours, then both knees hurt worse each day down to the shin bone.Consumer didn't want to stand up or walk on her legs due to the pain, and husband pulls her up out of a chair.Consumer walked on tread mill before synvisc-one injections, not after recalled injections; she measured her left knee after recalled injection and it was 1" larger.Consumer denied swelling or redness of the right knee, both feet are slightly puffy.Consumer was weight bearing before recalled injections and weight bearing when necessary after recalled injections.Consumer denied using support devices before or after recalled injections.Consumer used diclofenac sodium topical gel 1% a dozen times a day and every hour at night for pain.Patient reported that she had not recovered and had constant pain.She denied fever, lab work, hospitalization.Consumer had taken a few aspirin for pain after injections.It was reported that the injection did not work, pain was still in knees and blood work done was normal.Corrective treatment: diclofenac sodium topical gel 1%, aspirin for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees; not reported for other events outcome: not recovered for right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees and device malfunction; unknown for other events (except for injection did not work ) seriousness criteria: important medical event for 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Additional information was received on 08-mar-2018 from the patient.Event term was updated from right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain to right knee hurt after the injection/knees hurt worse each day down shin bone/didn't want to stand up or walk on legs due to the pain,knee pain/ pain is still in knees.Additional event of injection did not work was added along with details.Clinical course was updated.Text was amended accordingly.Follow up was received on 10-mar-2018.Gptc number added.Text amended accordingly.Additional information was received on (b)(6) 2018.Therapy start date for the suspect product synvisc one was updated.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 10-mar-2018: the follow up information received does not change the previous case assessment.This case concerns a female patient who received treatment with a recalled lot of synvisc one and experienced decreased mobility, swelling if limbs and knee pain.The role of the device cannot be denied for the occurrence of the event based upon the available information.Further the concerned lot number has been identified to have malfunction.Therefore, the causal role of the device in the development of events cannot be denied.
 
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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 Key7285186
MDR Text Key100924807
Report Number2246315-2018-00325
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 02/09/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/21/2018
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 Received03/19/2018
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age80 YR
Patient Weight70
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