MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Muscular Rigidity (1968); Pain (1994); Swelling (2091); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 28-dec-2017 from a patient.This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency had pretty severe pain/ whole leg hurt, from butt to foot, couldn't walk, discomfort, knee stiff, knee sore and lot of swelling.Also device malfunction was identified for the reported lot number.No past drug, concomitant medication or concurrent condition was provided.The patient's medical history was significant for bone on bone (x-rays of right knee revealed very little cartridge; got left knee repaired; only thing that would fix it was a knee replacement).On (b)(6) 2017, in the afternoon, the patient initiated treatment with intra-articular synvisc one injection at a dose of 1 df once for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the right knee and it wasn't until the next morning when he woke up that he had symptoms.On an unknown date in 2017, the patient's knee was stiff and sore.But it got continually worse and lasted for a good three weeks.It was reported that the patient was doing quite a bit better now and was about to the point where he was before he got the injection when his knee had bothered him a bit.On an unknown date in 2017, after unknown latency, the patient had a reaction to it and was in pretty severe pain.The patient's whole leg was hurt.It was from butt to foot and that lasted a week or more.On an unknown date in 2017, the patient couldn't walk for three days without help and then it started to get a little better.The patient was told to keep it iced and take ibuprofen (advil) for the discomfort but that didn't do much for him.It was reported that the patient had improved now and could walk and use his right leg.It was reported that the patient's knee did not bother him too much about like it was before the injection.The discomfort lessened after a week but stayed pretty uncomfortable.The pain went from an 8 to a 4.It was reported that the patient used a cane a little over 2 weeks to assist with walking and it steadily improved.Corrective treatment: ice and ibuprofen (advil) for pretty severe pain/ whole leg hurt, from butt to foot and knee sore; used a cane for couldn't walk; ice for lot of swelling outcome: recovering for all the events 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 04-jan-2017: this case concern a male patient who received synvisc one injection from the recalled lot for osteoarthritis and had pretty severe pain/ whole leg hurt, from butt to foot, couldn't walk, had discomfort, lot of swelling and knee also got stiff and sore.The concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event to the products cannot be excluded.

Event Description

This unsolicited case from united states was received on (b)(6) 2017 from a patient.This case concerns a (b)(6) male patient who received treatment with synvisc one and later after few hours had pretty severe pain/ whole leg hurt, from butt to foot/pain in my right leg/hurt from my hip to my foot, swelling in my right leg and after unknown latency couldn't walk, discomfort, knee stiff, knee sore and lot of swelling.Also device malfunction was identified for the reported lot number.No past drug was provided.The patient's medical history was significant for bone on bone (x-rays of right knee revealed very little cartridge; got left knee repaired; only thing that would fix it was a knee replacement).Concomitant medication included rosuvastatin for high blood pressure and high cholesterol, amlodipine and hydrochlorothiazide/ losartan.On (b)(6) 2017, in the afternoon at 03:00 pm, the patient received treatment with intra-articular synvisc one injection at a dose of 1 df once for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the right knee and it wasn't until the next morning when he woke up that he had symptoms.On (b)(6) 2017, few hours after the injection, patient experienced pain and swelling in right leg for two and a half week and it hurted from hip to foot.On an unknown date in 2017, the patient's knee was stiff and sore.But it got continually worse and lasted for a good three weeks.It was reported that the patient was doing quite a bit better now and was about to the point where he was before he got the injection when his knee had bothered him a bit.On an unknown date in 2017, after unknown latency, the patient had a reaction to it and was in pretty severe pain.The patient's whole leg was hurt.It was from butt to foot and that lasted a week or more.On an unknown date in 2017, the patient couldn't walk for three days without help and then it started to get a little better.The patient was told to keep it iced and take ibuprofen (advil) for the discomfort but that didn't do much for him.It was reported that the patient had improved now and could walk and use his right leg.It was reported that the patient's knee did not bother him too much about like it was before the injection.The discomfort lessened after a week but stayed pretty uncomfortable.The pain went from an 8 to 4.It was reported that the patient used a cane a little over 2 weeks to assist with walking and it steadily improved.As of (b)(6) 2018, it was reported that the pain and swelling was there but not that bad.Corrective treatment: ice and ibuprofen (advil) for pretty severe pain/ whole leg hurt, from butt to foot and knee sore; used a cane for couldn't walk; ice for lot of swelling, none for swelling in my right leg and not reported for other events outcome: recovering for all the events a pharmaceutical technical complaint was initiated with global ptc number: 51668 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: disability for device malfunction and couldn't walk additional information was received on 12-jan-2018 from patient.Patient's height was added.Concomitant medications and concurrent conditions were added.Additional event of swelling in my right leg was added along with details.The event term pretty severe pain/ whole leg hurt, from butt to foot was updated to pretty severe pain/ whole leg hurt, from butt to foot/pain in my right leg/hurt from my hip to my foot and event onset date was updated from 2017 to (b)(6) 2017.Upon internal review the event couldn't walk was updated to serious.Seriousness criteria of device malfunction was updated to disability.Clinical course was updated and text was amended accordingly.Follow up was received on 15-jan-2018.Global ptc number was added.Additional information was received on 06-feb-2018 from the patient.Event start date was updated for the events of pretty severe pain/ whole leg hurt, from butt to foot/pain in my right leg/hurt from my hip to my foot and swelling in my right leg.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 06-feb-2018: the follow up information did not change the previous case assessment.This case concern a male patient who received synvisc one injection from the recalled lot for osteoarthritis and had pretty severe pain/ whole leg hurt, from butt to foot, couldn't walk, had discomfort, lot of swelling and knee also got stiff and sore.The concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event to the products cannot be excluded.

Event Description

This unsolicited case from united states was received on 28-dec-2017 from a patient.This case concerns a (b)(6) year old male patient who received treatment with synvisc one and later after few hours had pretty severe pain/ whole leg hurt, from butt to foot/pain in my right leg/hurt from my hip to my foot, swelling in my right leg and after unknown latency couldn't walk, discomfort, knee stiff, knee sore and lot of swelling.Also device malfunction was identified for the reported lot number.No past drug was provided.The patient's medical history was significant for bone on bone (x-rays of right knee revealed very little cartridge; got left knee repaired; only thing that would fix it was a knee replacement).Concomitant medication included rosuvastatin for high blood pressure and high cholesterol, amlodipine and hydrochlorothiazide/ losartan.On (b)(6) 2017, in the afternoon at 03:00 pm, the patient received treatment with intra-articular synvisc one injection at a dose of 1 df once for osteoarthritis (batch/lot number: 7rsl021; expiry date: unknown) into the right knee and it wasn't until the next morning when he woke up that he had symptoms.On (b)(6) 2017, few hours after the injection, patient experienced pain and swelling in right leg for two and a half week and it hurted from hip to foot.On an unknown date in 2017, the patient's knee was stiff and sore.But it got continually worse and lasted for a good three weeks.It was reported that the patient was doing quite a bit better now and was about to the point where he was before he got the injection when his knee had bothered him a bit.On an unknown date in 2017, after unknown latency, the patient had a reaction to it and was in pretty severe pain.The patient's whole leg was hurt.It was from butt to foot and that lasted a week or more.On an unknown date in 2017, the patient couldn't walk for three days without help and then it started to get a little better.The patient was told to keep it iced and take ibuprofen (advil) for the discomfort but that didn't do much for him.It was reported that the patient had improved now and could walk and use his right leg.It was reported that the patient's knee did not bother him too much about like it was before the injection.The discomfort lessened after a week but stayed pretty uncomfortable.The pain went from an 8 to 4.It was reported that the patient used a cane a little over 2 weeks to assist with walking and it steadily improved.As of (b)(6) 2018, it was reported that the pain and swelling was there but not that bad.Corrective treatment: ice and ibuprofen (advil) for pretty severe pain/ whole leg hurt, from butt to foot and knee sore; used a cane for couldn't walk; ice for lot of swelling, none for swelling in my right leg and not reported for other events outcome: recovering for all the events 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: disability for device malfunction and couldn't walk additional information was received on 12-jan-2018 from patient.Patient's height was added.Concomitant medications and concurrent conditions were added.Additional event of swelling in my right leg was added along with details.The event term pretty severe pain/ whole leg hurt, from butt to foot was updated to pretty severe pain/ whole leg hurt, from butt to foot/pain in my right leg/hurt from my hip to my foot and event onset date was updated from 2017 to (b)(6) 2017.Upon internal review the event couldn't walk was updated to serious.Seriousness criteria of device malfunction was updated to disability.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 12-jan-2017: the follow up information did not change the previous case assessment.This case concern a male patient who received synvisc one injection from the recalled lot for osteoarthritis and had pretty severe pain/ whole leg hurt, from butt to foot, couldn't walk, had discomfort, lot of swelling and knee also got stiff and sore.The concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the event to the products cannot be excluded.

• 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 Key: 7211760
• MDR Text Key: 98602245
• Report Number: 2246315-2018-00063
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2017

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 Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 01/12/2018; 02/06/2018
• Supplement Dates FDA Received: 01/25/2018; 02/19/2018
• Patient Sequence Number: 1
• Treatment: AMLODIPINE(CON.); AMLODIPINE(CON.); HYDROCHLOROTHIAZIDE/LOSARTAN(CON.); HYDROCHLOROTHIAZIDE/LOSARTAN(CON.); ROSUVASTATIN(CON.); ROSUVASTATIN(CON.)
• Patient Outcome(s): Other; Disability
• Patient Age: 72 YR