MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Pain (1994); Arthralgia (2355); Joint Disorder (2373); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 11/30/2017

Event Type Injury

Event Description

Based on additional information received on 18-dec- 2017, this case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from the patient.This case concerns a (b)(6) year old male patient who received treatment with synvisc one injection and after 12 hours of receiving injection had severe pain in entire leg, after few hours patient was still cramping, leg got very stiff, pain in the knee and swelling in the knee; after unknown latency patient could not walk, could not sleep.No concurrent condition was provided.Patient was taking synvisc one for years every 6 months.Patient had diabetes.Patient had penicillin allergy.Concomitant medications include olmesartan medoxomil (benicar), glimepiride, amlodipine and saxagliptin hydrochloride (onglyza).On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection (batch/lot number, expiration date, dose, frequency: not provided) for knee trouble.On the same day, about 12 hours of receiving injection, patient had severe pain in entire leg.On the same day, after few hours of receiving injection, it was reported that leg got very stiff.It persisted severely for two days.Leg was not right for almost one week after injection.Patient was still cramping.Patient was given cortisone injection to calm pain.Patient had pain in the knee and swelling in the knee (onset date: (b)(6) 2017).On an unspecified date, after unknown latency, patient experienced could not walk, could not sleep.Patient consulted health care professional on (b)(6) 2017 and was seen in person on (b)(6) 2017.Patient did not visited emergency room.Action taken: unknown corrective treatment: cortisone injection for severe pain in entire leg; not reported for rest events outcome: unknown for could not sleep, could not walk, pain in the knee, swelling in the knee; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) the product lot number was not provided; therefore a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: required intervention for severe pain in entire leg follow up was received on 21-dec-2017.No new information was received.Additional information was received on 18-dec-2017 and 21-dec-2017 (both information processed together with clock start date of 18-dec-2017).This case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.Events of severe pain in entire leg, still cramping and leg got very stiff were added along with its details.Concomitant medications and medical history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 03-feb-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 3-feb-2018.The new follow up information received does not change previous case assessment.This case concerns a patient who received synvisc one injection and later had severe pain in leg for which patient received cortisone injection.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.

Event Description

Based on additional information received on 18-dec- 2017, this case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from the patient.This case concerns a (b)(6) year old male patient who received treatment with synvisc one injection and after 12 hours of receiving injection had severe pain in entire leg, after few hours patient was still cramping, leg got very stiff, pain in the knee and swelling in the knee; after unknown latency patient could not walk, could not sleep.No concurrent condition was provided.Patient was taking synvisc one for years every 6 months.Patient had diabetes.Patient had penicillin allergy.Concomitant medications include olmesartan medoxomil (benicar), glimepiride, amlodipine and saxagliptin hydrochloride (onglyza).On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection (batch/lot number, expiration date, dose, frequency: not provided) for knee trouble.On the same day, about 12 hours of receiving injection, patient had severe pain in entire leg.On the same day, after few hours of receiving injection, it was reported that leg got very stiff.It persisted severely for two days.Leg was not right for almost one week after injection.Patient was still cramping.Patient was given cortisone injection to calm pain.Patient had pain in the knee and swelling in the knee (onset date: (b)(6) 2017).On an unspecified date, after unknown latency, patient experienced could not walk, could not sleep.Patient consulted health care professional on (b)(6) 2017 and was seen in person on (b)(6) 2017.Patient did not visited emergency room.It was reported that the pain in knee lasted for 10 days after injection.It was reported that the physician gave him a shot of cortisone.He said it was still hurting.Action taken: unknown corrective treatment: cortisone injection for severe pain in entire leg and pain in the knee; not reported for rest events outcome: unknown for could not sleep, could not walk, swelling in the knee; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) the product lot number was not provided; therefore a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: required intervention for severe pain in entire leg and pain in the knee follow up was received on 21-dec-2017.No new information was received.Additional information was received on 18-dec-2017 and 21-dec-2017 (both information processed together with clock start date of 18-dec-2017).This case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.Events of severe pain in entire leg, still cramping and leg got very stiff were added along with its details.Concomitant medications and medical history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 03-feb-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 14-feb-2018 from the patient.Outcome for the event of pain in the knee updated from unknown to not recovered.Corrective treatment for the event of pain in the knee added and the event was upgraded to serious.Patient's clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 14-feb-2018.The new follow up information received does not change previous case assessment.This case concerns a patient who received synvisc one injection and later had severe pain in leg for which patient received cortisone injection.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.

Event Description

Based on additional information received on 18-dec- 2017, this case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.This case was cross referenced with (b)(4) (cluster).This unsolicited case from united states was received on 08-dec-2017 from the patient.This case concerns a (b)(6) year old male patient who received treatment with synvisc one injection and after 12 hours of receiving injection had severe pain in entire leg, after few hours patient was still cramping, leg got very stiff, pain in the knee/ knee is actually bad right now and painful and swelling in the knee; after unknown latency patient could not walk, could not sleep.No concurrent condition was provided.Patient was taking synvisc one for years every 6 months.Patient had diabetes.Patient had penicillin allergy.Concomitant medications include olmesartan medoxomil (benicar), glimepiride, amlodipine and saxagliptin hydrochloride (onglyza).On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection (batch/lot number, expiration date, dose, frequency: not provided) for knee trouble.On the same day, about 12 hours of receiving injection, patient had severe pain in entire leg.On the same day, after few hours of receiving injection, it was reported that leg got very stiff.It persisted severely for two days.Leg was not right for almost one week after injection.Patient was still cramping.Patient was given cortisone injection to calm pain.Patient had pain in the knee and swelling in the knee (onset date: (b)(6) 2017).On an unspecified date, after unknown latency, patient experienced could not walk, could not sleep.Patient consulted health care professional on (b)(6) 2017 and was seen in person on (b)(6) 2017.Patient did not visited emergency room.It was reported that the pain in knee lasted for 10 days after injection.It was reported that the physician gave him a shot of cortisone.He said it was still hurting.The patient was injected with bad synvisc one and had a lot of trouble with knee for 10 days after that.The knee was actually bad right now and painful.The patient was asking if he was injected with the actual product or was it something else and would that injection still be effective for 6 months even though it was recalled.Action taken: unknown corrective treatment: cortisone injection for severe pain in entire leg and pain in the knee/ knee is actually bad right now and painful; not reported for rest events outcome: unknown for could not sleep, could not walk, swelling in the knee; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4) the product lot number was not provided; therefore a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: required intervention for severe pain in entire leg and pain in the knee follow up was received on 21-dec-2017.No new information was received.Additional information was received on 18-dec-2017 and 21-dec-2017 (both information processed together with clock start date of 18-dec-2017).This case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.Events of severe pain in entire leg, still cramping and leg got very stiff were added along with its details.Concomitant medications and medical history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 03-feb-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 14-feb-2018 from the patient.Outcome for the event of pain in the knee updated from unknown to not recovered.Corrective treatment for the event of pain in the knee added and the event was upgraded to serious.Patient's clinical course was updated and text was amended accordingly.Additional information was received on 20-feb-2018 from patient.The event of pain in the knee was updated to pain in the knee/ knee is actually bad right now and painful.Clinical course was updated.Text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 20-feb-2018.The new follow up information received does not change previous case assessment.This case concerns a patient who received synvisc one injection and later had severe pain in leg for which patient received cortisone injection.Based upon the information available, the causal role of the product cannot be denied for the occurrence of events.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Further information regarding patient's current clinical presentation, indication of the suspected product, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.

Event Description

Severe pain in entire leg [leg pain] pain in the knee/ knee is actually bad right now and painful [knee pain] ([pain upon movement]) grating sensation in both knees [crepitations] antalgic gait [antalgic gait] could not sleep [poor quality sleep] still cramping [cramp] no full range of motion of the knees [joint range of motion decreased] leg got very stiff [limbs stiffness] could not walk [unable to walk] fall [fall] fatigue [fatigue] knee joint stiffness [joint stiffness] swelling in the knee/ swelling of both knees [swelling of r knee] knee were tender on palpitation [tenderness] worse in the morning [condition worsened].Case narrative: based on additional information received on 18-dec-2017, this case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.This case was cross referenced with (b)(4).This unsolicited case from united states was received on 08-dec-2017 from the patient.This case concerns a 76 year old male patient who received treatment with synvisc one injection and after 12 hours of receiving injection had severe pain in entire leg, after few hours patient was still cramping, leg got very stiff, grating sensation in both knees, pain in the knee/ knee is actually bad right now and painful and swelling in the knee/ swelling pf both knee; after unknown latency patient could not walk, could not sleep, antalgic gait, no full range of motion of the knees, fatigue and knee joint stiffness.Patient had medical history of chronic kidney disease stage 3, depression, diabetes mellitus diabetic peripheral neuropathy, diabetes mellitus type 2, esophagitis chronic reflux, gerd-reflux, hyperlipidemia, hypertension, inguinal hernia, leukemia lymphocytic chronic-b cell, leukemia lymphocytic chronic (cii) b-cell, nephrolithiasis with hyperuricuria, possible diabetes with diabetic retinopathy, osteoarthritis localised knee, restless legs syndrome, knee surgery, retinal detachment, gout, achilles tendon, alcohol use and deformity of toes.He also had colonoscopy in 2011.Patient's father had dm, cad, hypertension and juvenile idiopathic arthritis.His mother had hypertension.Patient was taking synvisc one for years every 6 months.Patient had penicillin allergy.Concomitant medications include olmesartan medoxomil (benicar), glimepiride, amlodipine saxagliptin hydrochloride (onglyza), glimepiride (amaryl), acetylsalicylic acid (aspirin), fish oil, pitavastatin calcium (livalo), amlodipine besilate (norvasc), pantoprazole sodium, tramadol hcl, vitamin b 12, alprazolam (xanax), mupirocin (bactroban) and losartan potassium.On 30-nov-2017, patient received treatment with intra- articular synvisc one injection (batch/lot number, expiration date, dose, frequency: not provided) for knee trouble.On the same day, about 12 hours of receiving injection, patient had severe pain in entire leg.On the same day, after few hours of receiving injection, it was reported that leg got very stiff.It persisted severely for two days.Leg was not right for almost one week after injection.Patient was still cramping.Patient was given cortisone injection to calm pain.Patient had pain in the knee and swelling in the knee (onset date: (b)(6) 2017).On an unspecified date, after unknown latency, patient experienced could not walk, could not sleep.Patient consulted health care professional on (b)(6) 2017 and was seen in person on (b)(6) 2017.On the same day, when patient was presented in the healthcare facility and at that time he was having fatigue.On the same day, it was also stated that patient was also having right knee joint pain and it was worse while standing, worsened in the morning, appeared with prolonged sitting and causing inability to sleep.No full range of motion of the knees was observed.Patient was also showing antalgic gait.It was also reported that joint pain in both knees when actively moved, worse with weightbearing, appeared with prolonged sitting, occurred at rest and was increased by twisting it.On the same day, aristospan 40 mg and 0.5 cc marcaine was injected in the right knee.Patient did not visited emergency room.It was reported that the pain in knee lasted for 10 days after injection.It was reported that the physician gave him a shot of cortisone.He said it was still hurting.The patient was injected with bad synvisc one and had a lot of trouble with knee for 10 days after that.The knee was actually bad right now and painful.The patient was asking if he was injected with the actual product or was it something else and would that injection still be effective for 6 months even though it was recalled.Action taken: not applicable.Corrective treatment: cortisone injection, aristopan and tylenol for severe pain in entire leg and pain in the knee/ knee is actually bad right now and painful; not reported for rest events.Outcome: unknown for could not sleep, could not walk, swelling in the knee/ swelling in both knees, fall, antalgic gait, fatigue and knee joint stiffness; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).The product lot number was not provided; therefore a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: required intervention for severe pain in entire leg and pain in the knee follow up was received on 21-dec-2017.No new information was received.Additional information was received on 18-dec-2017 and 21-dec-2017 (both information processed together with clock start date of 18-dec-2017).This case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.Events of severe pain in entire leg, still cramping and leg got very stiff were added along with its details.Concomitant medications and medical history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 03-feb-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 14-feb-2018 from the patient.Outcome for the event of pain in the knee updated from unknown to not recovered.Corrective treatment for the event of pain in the knee added and the event was upgraded to serious.Patient's clinical course was updated and text was amended accordingly.Additional information was received on 20-feb-2018 from patient.The event of pain in the knee was updated to pain in the knee/ knee is actually bad right now and painful.Clinical course was updated.Text amended accordingly.Additional information was received on 07-feb-2019 from the lawyer.Case updated to legal case.Medical history of patient with chronic kidney disease stage 3, depression, diabetes mellitus diabetic peripheral neuropathy, diabetes mellitus type 2, esophagitis chronic reflux, gerd-reflux, hyperlipidemia, hypertension, inguinal hernia, leukemia lymphocytic chronic-b cell, leukemia lymphocytic chronic (cii) b-cell, nephrolithiasis with hyperuricuria, possible diabetes with diabetic retinopathy, osteoarthritis localised knee, restless legs syndrome, knee surgery, retinal detachment, gout, achilles tendon and alcohol use.Medical history of patient's family was added.Concurrent medications updated.Events of antalgic gait, no full range of motion of the knees, fatigue and knee joint stiffness added.Corrective treatment added.Action taken was updated to not applicable from unknown.Related case id was added.Clinical course updated.Text amended accordingly.

Event Description

Device malfunction [device malfunction] severe pain in entire leg [leg pain] pain in the knee/ knee is actually bad right now and painful [knee pain] ([condition worsened], [pain upon movement]) swelling in the knee [knee swelling] could not sleep [poor quality sleep] still cramping [cramp] leg got very stiff [limbs stiffness] fall [fall] fatigue [fatigue] could not walk [unable to walk] knee joint stiffness [joint stiffness] case narrative: based on additional information received on 18-dec-2017, this case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.This case was cross referenced with (b)(6) (same patient) and (b)(6) (cluster).This unsolicited valid serious case from united states was received on 08-dec-2017 from the patient.This case concerns a 76 year old male patient who received treatment with synvisc one injection and after 12 hours of receiving injection had severe pain in entire leg, after few hours patient was still cramping, leg got very stiff, pain in the knee/ knee is actually bad right now and painful and swelling in the knee; after unknown latency, patient could not walk, could not sleep, fatigue and knee joint stiffness.Also device malfunction was reported with the concerned lot number patient had medical history of chronic kidney disease stage 3, depression, diabetes mellitus diabetic peripheral neuropathy, diabetes mellitus type 2, esophagitis chronic reflux, gerd-reflux, hyperlipidemia, essential hypertension benign, hypertension (systemic), inguinal hernia, fatigue, chronic knee pain/both knees tender on palpitation, knee joint stiffness (worse in morning), localized swelling of both knees, antalgic gait, no full range of motion of the knees, grating sensation in both knees, inability to sleep, leukemia lymphocytic chronic-b cell, leukemia lymphocytic chronic (cii) b-cell, nephrolithiasis with hyperuricuria, possible diabetes with diabetic retinopathy, osteoarthritis localised knee, restless legs syndrome, knee surgery, retinal detachment, gout, achilles tendon, weakness, knee weakness, alcohol use and deformity of toes, non-smoker.He also had colonoscopy in 2011.Patient's father had dm, cad, hypertension and juvenile idiopathic arthritis.His mother had hypertension.Patient was taking synvisc one for years every 6 months.Patient had penicillin allergy (reaction: skin rashes, hives).Concomitant medications include olmesartan medoxomil (benicar), glimepiride, amlodipine saxagliptin hydrochloride (onglyza), glimepiride (amaryl), acetylsalicylic acid (aspirin), fish oil, pitavastatin calcium (livalo), amlodipine besilate (norvasc), pantoprazole sodium, tramadol hcl for chronic intractable pain (knee pain), vitamin b 12, alprazolam (xanax), mupirocin (bactroban) and losartan potassium.Patient was advised to use cane (prn), tramadol, warm/cold compress, otc analgesics, liniments as directed for chronic knee pain.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection, 6ml, once for unilateral primary osteoarthritis of right knee (batch number: 7rsl021, expiration date: 01-may-2020).Patient was advised to follow up in approx.1 month to monitor response and evaluate reaction and non-reaction treatment process.Also, patient was advised to rest joint for 2 days and to apply cold pack for 10-15 min every 3-4 hours.On the same day of injection, about 12 hours of receiving injection, patient had severe pain in entire leg (required medical intervention).On the same day, after few hours of receiving injection, it was reported that leg got very stiff.It persisted severely for two days.Leg was not right for almost one week after injection.Patient was still cramping.Patient was given cortisone injection to calm pain.Patient had pain in the knee (required medical intervention) and swelling in the knee (onset date: (b)(6) 2017).On an unspecified date, after unknown latency, patient experienced could not walk, could not sleep.Patient consulted health care professional on (b)(6) 2017 and was seen in person on (b)(6) 2017.On the same day, when patient was presented in the healthcare facility and at that time he was having fatigue.On the same day, it was also stated that patient was also having right knee joint pain and it was worse while standing, worsened in the morning, appeared with prolonged sitting and causing inability to sleep.No full range of motion of the knees was observed.Patient was also showing antalgic gait.It was also reported that joint pain in both knees when actively moved, worse with weightbearing, appeared with prolonged sitting, occurred at rest and was increased by twisting it.On the same day, aristospan 40 mg and 0.5 cc marcaine was injected in the right knee.Patient did not visited emergency room.It was reported that the pain in knee lasted for 10 days after injection.It was reported that the physician gave him a shot of cortisone.He said it was still hurting.The patient was injected with bad synvisc one and had a lot of trouble with knee for 10 days after that.The knee was actually bad right now and painful.The patient was asking if he was injected with the actual product or was it something else and would that injection still be effective for 6 months even though it was recalled.Action taken: not applicable corrective treatment: cortisone injection, aristopan and tylenol for severe pain in entire leg, pain in the knee/ knee is actually bad right now and painful, swelling in the knee; not reported for rest events outcome: unknown for could not sleep, could not walk, swelling in the knee/ swelling in both knees, fall, fatigue and knee joint stiffness; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 51028 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.Follow up was received on 21-dec-2017.No new information was received.Additional information was received on 18-dec-2017 and 21-dec-2017 (both information processed together with clock start date of (b)(6) 2017).This case initially considered as non-serious was upgraded to serious as the event of severe pain in entire leg was added with seriousness criterion as required intervention.Events of severe pain in entire leg, still cramping and leg got very stiff were added along with its details.Concomitant medications and medical history was added.Clinical course updated.Text was amended accordingly.Additional information was received on 03-feb-2018.Global ptc number and ptc results were added.Clinical course updated.Text was amended accordingly.Additional information was received on 14-feb-2018 from the patient.Outcome for the event of pain in the knee updated from unknown to not recovered.Corrective treatment for the event of pain in the knee added and the event was upgraded to serious.Patient's clinical course was updated and text was amended accordingly.Additional information was received on 20-feb-2018 from patient.The event of pain in the knee was updated to pain in the knee/ knee is actually bad right now and painful.Clinical course was updated.Text amended accordingly.Additional information was received on 07-feb-2019 from the lawyer.Case updated to legal case.Medical history of patient with chronic kidney disease stage 3, depression, diabetes mellitus diabetic peripheral neuropathy, diabetes mellitus type 2, esophagitis chronic reflux, gerd-reflux, hyperlipidemia, hypertension, inguinal hernia, leukemia lymphocytic chronic-b cell, leukemia lymphocytic chronic (cii) b-cell, nephrolithiasis with hyperuricuria, possible diabetes with diabetic retinopathy, osteoarthritis localised knee, restless legs syndrome, knee surgery, retinal detachment, gout, achilles tendon and alcohol use.Medical history of patient's family was added.Concurrent medications updated.Events of antalgic gait, no full range of motion of the knees, fatigue and knee joint stiffness added.Corrective treatment added.Action taken was updated to not applicable from unknown.Related case id was added.Clinical course updated.Text amended accordingly.Additional information received on 28-jun-2019 from the lawyer.Batch lot number added.Suspect details updated.Medical history added.Corrective treatment added.Events of no full range of motion of the knees, grating sensation in both knees were deleted and updated as medical history.Clinical course updated.Text amended accordingly.

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Brand Name

SYNVISC ONE

Type of Device

MOZ

Manufacturer (Section D)

GENZYME CORPORATION(RIDGEFIELD)

1125 pleasantview terrace

ridgefield NJ 07657

MDR Report Key

7199537

MDR Text Key

97528304

Report Number

2246315-2018-00145

Device Sequence Number

Product Code

MOZ

Combination Product (y/n)

PMA/PMN Number

P940015

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer

Remedial Action

Recall

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Other

Device Expiration Date

05/01/2020

Device Lot Number

7RSL021

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Initial Date Manufacturer Received

12/18/2017

Initial Date FDA Received

01/17/2018

Supplement Dates Manufacturer Received

02/03/2018
02/14/2018
02/20/2018
02/20/2018
02/20/2018

Supplement Dates FDA Received

02/15/2018
02/22/2018
03/06/2018
02/20/2019
07/05/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

AMARYL (GLIMEPIRIDE),TABLET; AMARYL (GLIMEPIRIDE),TABLET; AMLODIPINE (AMLODIPINE),UNKNOWN; AMLODIPINE (AMLODIPINE),UNKNOWN; AMLODIPINE(CON.); AMLODIPINE(CON.); AMLODIPINE(CON.); AMLODIPINE(CON.); ASPIRIN [ACETYLSALICYLIC ACID],TABLET; ASPIRIN [ACETYLSALICYLIC ACID],TABLET; BACTROBAN [MUPIROCIN] (MUPIROCIN),OINTMENT; BACTROBAN [MUPIROCIN] (MUPIROCIN),OINTMENT; BENICAR (OLMESARTAN MEDOXOMIL),UNKNOWN; BENICAR (OLMESARTAN MEDOXOMIL),UNKNOWN; BENICAR(CON.); BENICAR(CON.); BENICAR(CON.); BENICAR(CON.); FISH OIL (FISH OIL),CAPSULE; FISH OIL (FISH OIL),CAPSULE; GLIMEPIRIDE (GLIMEPIRIDE),UNKNOWN; GLIMEPIRIDE (GLIMEPIRIDE),UNKNOWN; GLIMEPIRIDE(CON.); GLIMEPIRIDE(CON.); GLIMEPIRIDE(CON.); GLIMEPIRIDE(CON.); LIVALO (PITAVASTATIN CALCIUM),TABLET; LIVALO (PITAVASTATIN CALCIUM),TABLET; LOSARTAN POTASSIUM (LOSARTAN POTASSIUM),TABLET; LOSARTAN POTASSIUM (LOSARTAN POTASSIUM),TABLET; NORVASC (AMLODIPINE BESILATE),TABLET; NORVASC (AMLODIPINE BESILATE),TABLET; ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE),TABLET; ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE),TABLET; ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE),UNKNOWN; ONGLYZA (SAXAGLIPTIN HYDROCHLORIDE),UNKNOWN; ONGLYZA(CON.); ONGLYZA(CON.); ONGLYZA(CON.); ONGLYZA(CON.); PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM),TABLET; PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM),TABLET; PROTONIX [OMEPRAZOLE] (OMEPRAZOLE),TABLET; PROTONIX [OMEPRAZOLE] (OMEPRAZOLE),TABLET; TRAMADOL HCL (TRAMADOL HCL),TABLET; TRAMADOL HCL (TRAMADOL HCL),TABLET; VITAMIN B 12 (VITAMIN B12 NOS),LOZENGE; VITAMIN B 12 (VITAMIN B12 NOS),LOZENGE; XANAX (ALPRAZOLAM),TABLET; XANAX (ALPRAZOLAM),TABLET; AMLODIPINE(CON.); BENICAR(CON.); GLIMEPIRIDE(CON.); ONGLYZA(CON.)

Patient Outcome(s)

Required Intervention;

Patient Age

76 YR

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

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