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 Pain (1994); Swelling (2091); Burning Sensation (2146); Reaction, Injection Site (2442); Skin Inflammation (2443); Ambulation Difficulties (2544)

Event Date 11/23/2017

Event Type  malfunction  

Event Description

Based on the information received on 31-jan-2018, the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.(b)(4).This spontaneous case from united states was received on 22-jan-2018 from patient wife.This case concerns a (b)(6) male patient who initiated treatment with synvisc one and after 1 day had slight fever, was burning hot to the touch/very hot to touch, knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons/knee swelled to a very large point, pain was still there, couch ridden/stay on couch, could not walk on it, experiencing pain in the tendons, back of his legs; after an unknown latency couldn't drive, legs are restless, weird, in the back of his knees, like it affected the tendons in the back of his knees.Also, device malfunction was identified for the reported lot number.Patient had allergy to codeine- stomach.Concomitant medications include losartan potassium (losartan) and amlodipine for high blood pressure; rosuvastatin for triglyceride.The patient was not allergic to avian proteins, feathers, or egg products.The patient did not have any other medical conditions except high cholesterol levels.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once for knee pain (batch/ lot number: 7rsl021 and expiry date: unknown).On (b)(6) 2017, after a latency of 1 day, both knees blew up like a balloon.They were 3 times the size, burning hot to the touch, and he had a slight fever.It was reported that the right knee swelled to a very large point that patient could not walk on it for several days.Patient had to ice both the knees and stay on couch.It was reported that the knees swelled up like balloons, they were very hot to touch.The patient had been experiencing pain in the tendons, back of his legs.It was reported that the patient did not engage in activities such as jogging or tennis soon after the injection.On an unknown date, the swelling had come down.Both knees were affected, but the right was slightly worse than the left.He went home and rested the knees and iced them after the injection as instructed.He was couch ridden for 3 days.He couldn't drive, but did not use a cane or walker, etc (onset date unknown; latency unknown).He was not in the same town as his physician, so he just iced the area and rested it.No aspiration or blood work was done.The swelling had gone away, but the pain was still there.It was weird, in the back of his knees, like it affected the tendons in the back of his knees.He said it was more pain now than he had before he started using the synvisc-one.His legs were restless now especially when he lies down (onset date; unknown; latency unknown).Corrective treatment: rested the knees and iced them for pain is still there, knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons/knee swelled to a very large point, burning hot to the touch/very hot to touch.Outcome: unknown for experiencing pain in the tendons, back of his legs; not recovered for rest 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction.Additional information was received on 31-jan-2018 and 06-feb-2018 (both information processed together with clock start date of 31-jan-2018).This case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.Verbatim was updated for the event of couch ridden to couch ridden/stay on couch; burning hot to the touch to burning hot to the touch/very hot to touch; knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons to knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons/knee swelled to a very large point.Events of could not walk on it, experiencing pain in the tendons, back of his legs were added along with its details.Lot number was added.Medical history added.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 31-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced tendon pain, slight fever, impaired driving ability, restless legs, tendon disorder, mobility decreased, and was unable to wlak.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

Based on the information received on 31-jan-2018, the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.This case was cross reference with case id: (b)(4).This spontaneous case from united states was received on 22-jan-2018 from patient wife.This case concerns a 55 years old male patient who initiated treatment with synvisc one and after 1 day had slight fever, was burning hot to the touch/very hot to touch, knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons/knee swelled to a very large point, pain was still there, couch ridden/stay on couch, could not walk on it, experiencing pain in the tendons, back of his legs; after an unknown latency couldn't drive, legs are restless, weird, in the back of his knees, like it affected the tendons in the back of his knees.Also, device malfunction was identified for the reported lot number.Patient had allergy to codeine- stomach.Concomitant medications include depo-medrol,losartan potassium (losartan) and amlodipine for high blood pressure; rosuvastatin for triglyceride.The patient was not allergic to avian proteins, feathers, or egg products.The patient did not have any other medical conditions except high cholesterol levels.On 22-nov-2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once for knee pain (batch/ lot number: 7rsl021 and expiry date: 01-may-2020).On (b)(6) 2017, after a latency of 1 day, both knees blew up like a balloon.They were 3 times the size, burning hot to the touch, and he had a slight fever.It was reported that the right knee swelled to a very large point that patient could not walk on it for several days.Patient had to ice both the knees and stay on couch.It was reported that the knees swelled up like balloons, they were very hot to touch.The patient had been experiencing pain in the tendons, back of his legs.It was reported that the patient did not engage in activities such as jogging or tennis soon after the injection.On an unknown date, the swelling had come down.Both knees were affected, but the right was slightly worse than the left.He went home and rested the knees and iced them after the injection as instructed.He was couch ridden for 3 days.He couldn't drive, but did not use a cane or walker, etc (onset date unknown; latency unknown).He was not in the same town as his physician, so he just iced the area and rested it.No aspiration or blood work was done.The swelling had gone away, but the pain was still there.It was weird, in the back of his knees, like it affected the tendons in the back of his knees.He said it was more pain now than he had before he started using the synvisc-one.His legs were restless now especially when he lies down (onset date; unknown; latency unknown).Corrective treatment: rested the knees and iced them for pain is still there, knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons/knee swelled to a very large point, burning hot to the touch/very hot to touch outcome: unknown for experiencing pain in the tendons, back of his legs; not recovered for rest events a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52146 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.Seriousness criteria: important medical event for device malfunction additional information was received on 31-jan-2018 and 06-feb-2018 (both information processed together with clock start date of (b)(6) -2018).This case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction.Verbatim was updated for the event of couch ridden to couch ridden/stay on couch; burning hot to the touch to burning hot to the touch/very hot to touch; knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons to knees blew up like a balloon/3 times the size/swelling/knees swelled up like balloons/knee swelled to a very large point.Events of could not walk on it, experiencing pain in the tendons, back of his legs were added along with its details.Lot number was added.Medical history added.Clinical course was updated and text was amended accordingly.Follow up information was received on 22-feb-2018.Global ptc number was added.Additional information was received on 19-apr-2018 from healthcare professional.Expiration date for batch details added.Concomitant medication added.Pharmacovigilance comment: sanofi company comment follow up dated 19-apr-2018: the follow-up information does not alter the overall case assessment.Based on the provided information, 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.

• 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: 7276526
• MDR Text Key: 100530266
• Report Number: 2246315-2018-00302
• 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,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Patient Sequence Number: 1
• Treatment: AMLODIPINE(CON.) - ONGOING; AMLODIPINE(CON.) - ONGOING; CODEINE(PREV.); CODEINE(PREV.); DEPO-MEDROL(CON.); LOSARTAN(CON.) - ONGOING; LOSARTAN(CON.) - ONGOING; ROSUVASTATIN(CON.)-ONGOING; ROSUVASTATIN(CON.)-ONGOING
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 113