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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 Nonstandard Device (1420); Device Contamination With Biological Material (2908); Device Operates Differently Than Expected (2913)
Patient Problems Bacterial Infection (1735); Pain (1994); Swelling (2091)
Event Date 12/05/2017
Event Type  malfunction  
Event Description
This case was cross referenced with cases: (b)(4) (cluster).This spontaneous case from united states was received on 08-dec-2017 from a nurse.This case concerns a (b)(6) years old female patient who initiated treatment with synvisc one and after 26 days patient had very swollen knee, warm to touch at knee and worse pain, 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 at a dose of 1 df once for right knee arthritis (batch number: 7rsl021; expiry date: unknown).On (b)(6) 2017, after a latency of 26 days, patient complained of a very swollen, warm to touch at her knee and that this was the worse pain she has experience since the injection.She was told to rest, ice and elevate and take anti-inflammatory drugs.She was offered to come in to the office that day, but came in on (b)(6) 2017.It was determined to be a local reaction.She was told to rest, ice and elevate and take anti-inflammatory drugs again.Corrective treatment: not reported for all events.Outcome: not recovered for all 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 08-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot and later her knee was swollen, was warm to touch and had worse pain.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
Device malfunction [device malfunction].Some soreness [pain].Very swollen knee [swelling of l knee].Warm to touch at knee/ warm to touch [joint warmth].Worse pain [knee pain].Case narrative: this case was cross referenced with cases: (b)(4).This spontaneous case from united states was received on 08-dec-2017 from a nurse.This case concerns a 81 years old female patient who initiated treatment with synvisc one and after 26 days patient had very swollen knee, warm to touch at knee/warm to touch, some soreness and worse pain, also, device malfunction was identified for the reported lot number.Medical history included heartburn, gerd (gastroesophageal reflux disease), hypertension.Concomitant medications included atorvastatin, benzonatate, estradiol, mirabegron (myrbetriq) and olmesartan.No previous medications and concurrent conditions were reported.On (b)(6) 2017 , patient received treatment with intra articular synvisc one injection at a dose of 1 df once for right knee arthritis (batch number: 7rsl021; expiry date: unknown; batch number: 7rsl019; expiry date: 01-may-2020).On (b)(6) 2017 , after a latency of 26 days, patient complained of a very swollen/left knee swollen, warm to touch at her knee and that this was the worse pain she has experience since the injection.The patient denied fever or redness.She was told to rest, ice and elevate and take anti-inflammatory drugs.She was offered to come in to the office that day, but came in on (b)(6) 2017.It was determined to be a local reaction, exam benign, no evidence of infection or significant complication.She was told to rest, ice and elevate and take anti-inflammatory drugs again.On (b)(6) 2017 , followed up with patient, some soreness (event onset date and latency: unknown) but contributed to cold weather was reported.Corrective treatment: not reported for all events.Outcome: unknown for some soreness; not recovered for worse pain; recovered for warm to touch at knee/ warm to touch and very swollen knee.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.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).The production and quality control documentation for lot number 7rsl019 expiration date (05/2020) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number 7rsl019 no capa is required.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 safety surveillance effort to detect safety signals.This review has not indicated any safety issue.As of 09-may-18, there are 24 complaints on file for lot number 7rsl019: (24) adverse event reports.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440.Product complaint handling to determine if a capa is required.Additional information was received on 17-jan-2018.Global ptc number was added.Additional information was received on 09-apr-2018 from a nurse.Medical history and concomitant medications were added.The event term of warm to touch at knee was updated to warm to touch at knee/ warm to touch and outcome was updated from not recovered to recovered.Additional event of some soreness was added.Outcome for very swollen knee updated.The suspect drug's batch/lot number and expiration date was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 09-may-2018.Global ptc number was added and results were processed.
 
Event Description
This case was cross referenced with cases: (b)(4).This spontaneous case from united states was received on (b)(6)2017 from a nurse.This case concerns a 81 years old female patient who initiated treatment with synvisc one and after 26 days patient had very swollen knee, warm to touch at knee/ warm to touch, some soreness and worse pain, also, device malfunction was identified for the reported lot number.Medical history included heartburn, gerd (gastroesophageal reflux disease), hypertension.Concomitant medications included atorvastatin, benzonatate, estradiol, mirabegron (myrbetriq) and olmesartan.No previous medications and concurrent conditions were reported.On (b)(6)2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for right knee arthritis (batch number: 7rsl021; expiry date: unknown; batch number: 7rsl019; expiry date: 01- may-2020).On (b)(6)2017, after a latency of 26 days, patient complained of a very swollen/left knee swollen, warm to touch at her knee and that this was the worse pain she has experience since the injection.The patient denied fever or redness.She was told to rest, ice and elevate and take anti-inflammatory drugs.She was offered to come in to the office that day, but came in on (b)(6)2017.It was determined to be a local reaction, exam benign, no evidence of infection or significant complication.She was told to rest, ice and elevate and take anti-inflammatory drugs again.On (b)(6)2017, followed up with patient, some soreness (event onset date and latency: unknown) but contributed to cold weather was reported.Corrective treatment: not reported for all events outcome: unknown for some soreness; not recovered for worse pain; recovered for warm to touch at knee warm to touch and very swollen knee 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 17-jan-2018.Global ptc number was added.Additional information was received on 09-apr-2018 from a nurse.Medical history and concomitant medications were added.The event term of warm to touch at knee was updated to warm to touch at knee/ warm to touch and outcome was updated from not recovered to recovered.Additional event of some soreness was added.Outcome for very swollen knee updated.The suspect drug's batch/lot number and expiration date was added.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment fro follow up dated (b)(6) 2017: the follow up received does not change the previous assessment of the case.This case concerns a female patient who received synvisc one injection from the recalled lot and later her knee was swollen, was warm to touch and had worse pain.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 Name
SYNVISC ONE
Type of Device
MOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7177856
MDR Text Key97857744
Report Number2246315-2018-00095
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 health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2018
Patient Sequence Number1
Treatment
ATORVASTATIN (ATORVASTATIN),UNKNOWN; ATORVASTATIN(CON.); BENZONATATE (BENZONATATE),UNKNOWN; BENZONATATE(CON.); ESTRADIOL (ESTRADIOL),UNKNOWN; ESTRADIOL(CON.); MYRBETRIQ (MIRABEGRON),UNKNOWN; MYRBETRIQ(CON.); OLMESARTAN (OLMESARTAN),UNKNOWN; OLMESARTAN(CON.)
Patient Outcome(s) Other;
Patient Age81 YR
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