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 Edema (1820); Pain (1994); Swelling (2091); Toxicity (2333)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 17-jan-2018 from the patient this case concerns a (b)(6) female patient who initiated treatment with synvisc one and on the same day legs felt heavy like "logs", were painful, started to swell, couldn't flex his knees, swelling was substantial in both knees, after unknown latency had fluid in both knees, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.He got a prosthetic device in right hip 5 years ago.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose: not provided; batch/ lot number: 7rsl026a and expiry date: unknown) for arthritic knees.On the same day, patient was walking towards his car and his legs felt heavy like "logs".He stated they were painful and started to swell.The swelling was substantial in both knees but he did not measure them.He did not need support to walk.He stated that afterwards in the past he had flexibility in his knees but now he couldn't flex his knees (onset: (b)(6) 2017; latency: same day).He did not experience fever.There was no blood work or drainage of knees after the injections days after.The hcp offered to drain the knees and the consumer declined.He did apply ice to both knees.He can't remember if he took something for pain.His knees were functional now.The swelling had gone down but he still thought that he had some fluid in both knees (onset date 2017 and latency unknown).Corrective treatment: ice for couldn't flex his knees, swelling was substantial in both knees; not reported for legs felt heavy like "logs", painful and swelling and fluid in both knees outcome: recovering for legs felt heavy like "logs", device malfunction, started to swell, swelling was substantial in both knees; not recovered for fluid in both knees; 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 17-jan-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced heaviness in limbs, pain in legs, swelling in legs, joint range of motion decreased and knee swelling.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

This spontaneous case from united states was received on (b)(6) 2018 from the patient this case concerns a 71 years old male patient who initiated treatment with synvisc one and on the same day legs felt heavy like "logs", were painful, started to swell, couldn't flex his knees, swelling was substantial in both knees, severe pain both knees and had difficulty walking lasted 2 weeks; after unknown latency had fluid in both knees, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.He got a prosthetic device in right hip 5 years ago.Patient had a history of broken legs, ribs, low testosterone and hip replacement.Concomitant medications included: acetylsalicylic acid (aspirin), atorvastatin calcium (lipitor), testosterone (androgel) on (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose: not provided; batch/ lot number: 7rsl021a and expiry date: 01-may-2020) for arthritic knees.On the same day, patient was walking towards his car and his legs felt heavy like "logs".He stated they were painful and started to swell.The swelling was substantial in both knees but he did not measure them.Patient had severe swelling and pain in both knees and had difficulty walking.He did not need support to walk.He stated that afterwards in the past he had flexibility in his knees but now he couldn't flex his knees (onset: (b)(6) 2017; latency: same day).He did not experience fever.There was no blood work or drainage of knees after the injections days after.The hcp offered to drain the knees and the consumer declined.He did apply ice to both knees.He can't remember if he took something for pain.His knees were functional now.The swelling had gone down but he still thought that he had some fluid in both knees (onset date 2017 and latency unknown).Corrective treatment: ice for couldn't flex his knees, swelling was substantial in both knees/ severe swelling both knees; not reported for legs felt heavy like "logs", painful, severe pain both knees, difficulty walking lasted 2 weeks and started to swell and fluid in both knees outcome: recovering for legs felt heavy like "logs", device malfunction, started to swell; recovered for severe pain both knees, difficulty walking lasted 2 weeks, swelling was substantial in both knees/ severe swelling both knees; not recovered for fluid in both knees; unknown for other events a pharmaceutical technical complaint (ptc) was initiated with global ptc number 52056 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 follow up information was received on 23-jan-2018.Global ptc number was added.Text was amended accordingly.Additional information was received on 27-feb-2018 from the patient.Expiration date added.Events of difficulty walking lasted 2 weeks and severe pain both knees were added.Event of swelling was substantial in both knees was updated to swelling was substantial in both knees/ severe swelling both knees.Concomitant medications and medical history was added.Outcome for the event of swelling was substantial in both knees/ severe swelling both knees was updated from recovering to recovered.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 21-feb-18.The follow up received does not change the previous assessment of the case.This case concerns a patient who has received synvisc one injection from the recalled lot and later experienced heaviness in limbs, pain in legs, swelling in legs, joint range of motion dectreased and knee swelling.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: 7250622
• MDR Text Key: 100051358
• Report Number: 2246315-2018-00219
• 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
• Report Date: 01/17/2018

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: Physician
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/27/2018
• Supplement Dates FDA Received: 03/09/2018
• Patient Sequence Number: 1
• Treatment: ANDROGEL(CON.); ASPIRIN(CON.); LIPITOR(CON.)
• Patient Outcome(s): Other
• Patient Age: 71 YR