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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 07-feb-2018 from a patient.This case concerns a (b)(6) male patient who received treatment with synvisc one and later on the same day couldn't stand for long, when he would get up and move,it felt like cramping, his knee was swollen like a grapefruit, was red and it was painful/pain was about 7-8 on a scale of 0-10( 10 the worst)/3 weeks later it topped and went back to his normal arthritis pain.Also device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.The patient was not on immunosuppressants, no prosthetics except a mesh for a hernia.The patient never had a hylan product before.The patient had past treatment with cortisone injection.The patient had overall good health and was not allergic to bird products (only penicillin).On an unknown date in (b)(6) 2017 at around 10:00 a.M.To noon, the patient initiated treatment with intraarticular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021; indication and expiry date: unknown).The physician provided the syringe in the office, opened it there, cleaned the area with a disinfectant and gave the injection in his left knee.He did not inject anything else into the knee.He went home and took a nap.At 5 pm when the patient woke up his knee was swollen like a grapefruit and was red and painful.The same day, patient couldn't stand for long, but manned up until the following monday.It was reported that when he would get up and move, it felt like it was cramping.The same day, his pain was about 7-8 on a scale of 0-10 (10 the worst).About 2 days later, the pain started getting better.Reportedly, about 3 weeks later it topped and went back to his normal arthritis pain.He went to a different physician than the one who had given the injection on that monday.He did blood work and gave him an antibiotic (unspecified).It was reported that the first dose was a shot in his buttocks.He did not drain anything from his knee.He did not have a fever.Corrective treatment: not reported for device malfunction; antibiotics (unspecified) for rest of the events outcome: unknown 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 12-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced weight bearing difficulty, cramp, knee swelling, localized erythema and knee 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

Based on additional information received on 04-apr- 2018, the case became medically confirmed.This unsolicited case from united states was received on 07-feb-2018 from a patient.This case concerns a 42 year old male patient who received treatment with synvisc one and later on the same day couldn't stand for long, when he would get up and move,it felt like cramping, his knee was swollen like a grapefruit, was red/ left knee redness and it was painful/pain was about 7-8 on a scale of 0-10( 10 the worst)/3 weeks later it topped and went back to his normal arthritis pain/ sharp pain and pressure in left knee/ pain continued to get worse.Also device malfunction was identified for the reported lot number.No concurrent condition was provided.The patient was not on immunosuppressants, no prosthetics except a mesh for a hernia.The patient never had a hylan product before.The patient had past treatment with cortisone injection.The patient had overall good health and was not allergic to bird products (only penicillin).Patient was a former smoker and medical history was significant for left knee scope, gerd, anxiety, insomnia, bioxin intolerance, pcm rash.Patient's concomitant medication included paracetamol (tylenol) and ibuprofen.On (b)(6) 2017 at around 10:00 a.M.To noon, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021; indication and expiry date: unknown).The physician provided the syringe in the office, opened it there, cleaned the area with a disinfectant and gave the injection in his left knee.He did not inject anything else into the knee.He went home and took a nap.At 5 pm when the patient woke up his knee was swollen like a grapefruit and was red and painful.The same day, patient couldn't stand for long, but manned up until the following monday.It was further reported that 4 or 5 hours after injection started to feel sharp pain and pressure in left knee.It was reported that when he would get up and move, it felt like it was cramping.The same day, his pain was about 7-8 on a scale of 0-10 (10 the worst).About 2 days later, the pain started getting better.On 04-dec-2017, patient made an appointment with his doctor because his pain continued to get worse with redness and warmth noted after injection.Reportedly, about 3 weeks later it topped and went back to his normal arthritis pain.He went to a different physician than the one who had given the injection on that monday.He did blood work and gave him an antibiotic (unspecified).It was reported that the first dose was a shot in his buttocks.He did not drain anything from his knee.He did not have a fever.Corrective treatment: not reported for device malfunction; ceftriaxone sodium (rocephin) and clindamycin phosphate (clindamycin) for was red/ left knee redness and painful/pain was about 7-8 on a scale of 0-10( 10 the worst)/3 weeks later it topped and went back to his normal arthritis pain/ sharp pain and pressure in left knee/ pain continued to get worse; antibiotics (unspecified) for rest of the events outcome: recovered/ resolved for was red/ left knee redness and painful/pain was about 7-8 on a scale of 0-10( 10 the worst)/3 weeks later it topped and went back to his normal arthritis pain/ sharp pain and pressure in left knee/ pain continued to get worse; unknown for rest of the events a pharmaceutical technical complaint was initiated with global ptc number: 52473 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 follow up was received on 26-feb-2018.Global ptc (pharmaceutical technical complaint) number was added.Text was amended accordingly.Additional information was received on 04-apr-2018 from healthcare professional (patient's wife who is nurse).Event term was updated for the event of painful/pain was about 7-8 on a scale of 0-10( 10 the worst)/3 weeks later it topped and went back to his normal arthritis pain to painful/pain was about 7-8 on a scale of 0-10( 10 the worst)/3 weeks later it topped and went back to his normal arthritis pain/ sharp pain and pressure in left knee/ pain continued to get worse and was red to was red/ left knee redness.Corrective updated for both events.Concomitant medication and medical history updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 04-apr-2018: the causal role of the drug synvisc one cannot be denied for the reported events of device malfunction and bacterial arthritis, as the concerned lot number has been identified to have malfunction by the company.Additionally, the contributory role of both concomitant medications cannot be underestimated either.Also, medical history of knee operation act as confounder for the reported event of bacterial arthritis.

• 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: 7285106
• MDR Text Key: 100922649
• Report Number: 2246315-2018-00323
• Device Sequence Number: 0
• Product Code: MOZ
• 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: 02/07/2018
• 2 Devices were Involved in the Event: 1 2

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: 02/07/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 04/20/2018
• Patient Sequence Number: 1
• Treatment: CORTISONE(PREV.); CORTISONE(PREV.); IBUPROFEN(CON.); PARACETAMOL(PREV.); TYLENOL(CON.)
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 102