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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Connective Tissue Disease (1786); Pain (1994); Arthralgia (2355); Joint Disorder (2373); Fluid Discharge (2686)

Event Date 05/01/2018

Event Type  Injury  

Event Description

Aspirated 180 cc of fluid from the right knee and 120 cc from the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection [joint effusion].Equal or more pain than before the injection/ his knees were screaming [knee pain] ([condition aggravated]).No space (bone on bone) on the left.He no longer has any cartilage in the knee joint.[articular cartilage defect].Case narrative: this case upgrade to serious because of administration of cortisone as corrective.Initial information received on 30-may-2018 regarding an unsolicited valid non-serious case from united states was received from a consumer.This case involves a (b)(6) male patient who experienced aspirated 180 cc of fluid from the right knee and 120 cc fro the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection, equal or more pain than before the injection/ his knees were screaming and no space (bone on bone) on the left, he no longer has any cartilage in the knee joint, (latency: unknown) while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included arthralgia in 1960, hernia, urinary tract infection, sleep apnoea syndrome, transurethral prostatectomy and allergy to codeine which causes loss of all senses.The patient's past and family history were not provided.It was reported that the patient received cortisone injection in the past (for an unknown indication).Concomitant medications included cortisone, acetylsalicylic acid (aspirin 81) for cardiac disorder; benazepril hcl for blood pressure measurement; oxymetazoline hydrochloride (claritin allergic) for hypersensitivity; rosuvastatin calcium (crestor) for blood cholesterol; docusate sodium (doc-q-lace) for laxative supportive care; finasteride for unevaluable event; tamsulosin hydrochloride (flomax relief) for unevaluable event; diphenhydramine hydrochloride, ibuprofen (ibuprofen pm) for pain and sleep disorder; levothyroxine for thyroid disorder; ibuprofen for pain; magnesium for muscle spasms; methenamine hippurate for urine abnormality; famotidine (pepcid ac) for acidosis; antazoline phosphate, naphazoline hydrochloride (refresh eye allergy relief) for dry eye; areds2 eye vitamin, spironolactone (spironolactone) for diuretic therapy and testosterone for low testosterone levels.On an unknown date, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate (synvisc one) on an unknown dosage and frequency for arthralgia.On (b)(6) 2018, the physician aspirated 180 cc of fluid from the right knee and 120 cc from the left.On (b)(6) 2018, prior to the injection 80 cc fluid was aspirated from the right knee and 60 cc from the left knee.On the same day, patient received his latest injection of hylan g-f 20, sodium hyaluronate (synvisc one) on an unknown dose.On an unknown date in (b)(6) 2018, patient developed aspirated 180 cc of fluid from the right knee and 120 cc from the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection (joint effusion), equal or more pain than before the injection/ his knees were screaming (arthralgia) and no space (bone on bone) on the left/ he no longer has any cartilage in the knee joint.(chondropathy).It is unknown whether the patient recovered from the events or not.The patient also reported that he usually gets fluid on his knees about 2 months after the injection.Normally, in about 4 days, his knees feel better.This did not happen this time.He had equal or more pain than before the injection.He had a brace on one knee, but this did not help.The patient reported that he gets his blood tested for anemia and when he gets the cortisone injection, he cannot sleep the first night of the injection.Patient reported that the physician said his x-ray showed some space still on the right knee, but no space (bone on bone) on the left.He no longer has any cartilage in the knee joint.He didn't want to have knee replacement because he is older, is heavy, and has serious reactions to anesthesia.The patient reported of two other people who used synvisc and it worked for a long time, but then stopped working.One lady had to eventually have a knee replacement.The other was his wife, (b)(6), date of birth (b)(6), and she used synvisc 4-5 years ago and had to have a partial knee replacement a couple of years ago.The patient reported that he received cortisone in both knees and his knees were fine in 24 hours.On (b)(6) 2018, the patient discontinued synvisc one.Final diagnosis was aspirated 180 cc of fluid from the right knee and 120 cc from the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection, equal or more pain than before the injection/ his knees were screaming and no space (bone on bone) on the left/he no longer has any cartilage in the knee joint.Action taken: unknown.Corrective treatment: ibuprofen and aspiration for 180 cc of fluid from the right knee and 120 cc from the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection; cortisone injection.Outcome: unknown.A product technical complaint was initiated on 08-jun-2018 for synvisc-one.Batch number: unknown, global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformation prior to rel ease.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information received on 08-jun-2018.Investigation summary received and ptc results added.Clinical course updated.Text amended accordingly.Additional information was received on 13-jun-2018.Concomitant medications and patient's past medical history were reported.Text was amended accordingly.Information received on 09-jul-2018.No new information received.

Event Description

No space (bone on bone) on the left.No longer any cartilage in the knee joint.[articular cartilage defect] aspirated 180 cc of fluid from the right knee and 120 cc fron the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection [joint effusion] equal or more pain than before the injection/ his knees were screaming [knee pain] ([condition aggravated]).Case narrative: this case upgrade to serious because of administration of cortisone as corrective initial information received on 30-may-2018 regarding an unsolicited valid non-serious case from united states was received from a consumer.This case involves a 74 years old male patient who experienced aspirated 180 cc of fluid from the right knee and 120 cc fro the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection, equal or more pain than before the injection/ his knees were screaming and no space (bone on bone) on the left, he no longer has any cartilage in the knee joint, (latency: unknown) while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included arthralgia in 1960, hernia, urinary tract infection, sleep apnoea syndrome, transurethral prostatectomy and allergy to codeine which causes loss of all senses.The patient's past and family history were not provided.It was reported that the patient received cortisone injection in the past (for an unknown indication).Concomitant medications included cortisone, acetylsalicylic acid (aspirin 81) for cardiac disorder; benazepril hcl for blood pressure measurement; oxymetazoline hydrochloride (claritin allergic) for hypersensitivity; rosuvastatin calcium (crestor) for blood cholesterol; docusate sodium (doc-q-lace) for laxative supportive care; finasteride for unevaluable event; tamsulosin hydrochloride (flomax relief) for unevaluable event; diphenhydramine hydrochloride, ibuprofen (ibuprofen pm) for pain and sleep disorder; levothyroxine for thyroid disorder; ibuprofen for pain; magnesium for muscle spasms; methenamine hippurate for urine abnormality; famotidine (pepcid ac) for acidosis; antazoline phosphate, naphazoline hydrochloride (refresh eye allergy relief) for dry eye; areds2 eye vitamin, spironolactone (spironolactone) for diuretic therapy and testosterone for low testosterone levels.On an unknown date, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate (synvisc one) on an unknown dosage and frequency for arthralgia.On (b)(6) 2018, the physician aspirated 180 cc of fluid from the right knee and 120 cc from the left.On (b)(6) 2018, prior to the injection 80 cc fluid was aspirated from the right knee and 60 cc from the left knee.On the same day, patient received his latest injection of hylan g-f 20, sodium hyaluronate (synvisc one) on an unknown dose.On an unknown date in (b)(6) 2018, patient developed aspirated 180 cc of fluid from the right knee and 120 cc fron the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection (joint effusion), equal or more pain than before the injection/ his knees were screaming (arthralgia) and no space (bone on bone) on the left/ he no longer has any cartilage in the knee joint.(chondropathy).It is unknown whether the patient recovered from the events or not.The patient also reported that he usually gets fluid on his knees about 2 months after the injection.Normally, in about 4 days, his knees feel better.This did not happen this time.He had equal or more pain than before the injection.He had a brace on one knee, but this did not help.The patient reported that he gets his blood tested for anemia and when he gets the cortisone injection, he cannot sleep the first night of the injection.Patient reported that the physician said his x-ray showed some space still on the right knee, but no space (bone on bone) on the left.He no longer has any cartilage in the knee joint.He didn't want to have knee replacement because he is older, is heavy, and has serious reactions to anesthesia.The patient reported of two other people who used synvisc and it worked for a long time, but then stopped working.One lady had to eventually have a knee replacement.The other was his wife, trilby, date of birth 17apr1945, and she used synvisc 4-5 years ago and had to have a partial knee replacement a couple of years ago.The patient reported that he received cortisone in both knees and his knees were fine in 24 hours.On (b)(6) 2018, the patient discontinued synvisc one.Final diagnosis was aspirated 180 cc of fluid from the right knee and 120 cc fron the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection, equal or more pain than before the injection/ his knees were screaming and no space (bone on bone) on the left/he no longer has any cartilage in the knee joint.Action taken: unknown.Corrective treatment: ibuprofen and aspiration for 180 cc of fluid from the right knee and 120 cc fron the left knee/he aspirated 80 cc from the right and 60 cc from the left/he usually gets fluid on his knees about 2 months after the injection; cortisone injection outcome: unknown.A product technical complaint was initiated on (b)(6) 2018 for synvisc-one.Batch number: unknown global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information received on 08-jun-2018.Investigation summary received and ptc results added.Clinical course updated.Text amended accordingly.Additional information was received on 13-jun-2018.Concomitant medications and patient's past medical history were reported.Text was amended accordingly.Information received on 09-jul-2018.No new information received.Upon internal review on 27-nov-2018, the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7898107
• MDR Text Key: 121046102
• Report Number: 2246315-2018-00574
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 (ACETYLSALICYLIC ACID),UNKNOWN; ASPIRIN 81 (ACETYLSALICYLIC ACID),UNKNOWN; BENAZEPRIL HCL (BENAZEPRIL HCL),UNKNOWN; BENAZEPRIL HCL (BENAZEPRIL HCL),UNKNOWN; CLARITIN ALLERGIC,UNKNOWN; CLARITIN ALLERGIC,UNKNOWN; CORTISONE (CORTISONE),UNKNOWN; CORTISONE (CORTISONE),UNKNOWN; CRESTOR (ROSUVASTATIN CALCIUM),UNKNOWN; CRESTOR (ROSUVASTATIN CALCIUM),UNKNOWN; DOC-Q-LACE (DOCUSATE SODIUM),UNKNOWN; DOC-Q-LACE (DOCUSATE SODIUM),UNKNOWN; FINASTERIDE (FINASTERIDE),UNKNOWN; FINASTERIDE (FINASTERIDE),UNKNOWN; FLOMAX RELIEF (TAMSULOSIN HYDROCHLORIDE),UNKNOWN; FLOMAX RELIEF (TAMSULOSIN HYDROCHLORIDE),UNKNOWN; IBUPROFEN (IBUPROFEN),UNKNOWN; IBUPROFEN (IBUPROFEN),UNKNOWN; IBUPROFEN PM,UNKNOWN; IBUPROFEN PM,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; MAGNESIUM (MAGNESIUM),; MAGNESIUM (MAGNESIUM),; METHENAMINE HIPPURATE (METHENAMINE HIPPURATE),; METHENAMINE HIPPURATE (METHENAMINE HIPPURATE),; PEPCID AC (FAMOTIDINE),; PEPCID AC (FAMOTIDINE),; REFRESH EYE ALLERGY RELIEF,UNKNOWN; REFRESH EYE ALLERGY RELIEF,UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),; SPIRONOLACTONE (SPIRONOLACTONE),; TESTOSTERONE (TESTOSTERONE),; TESTOSTERONE (TESTOSTERONE),; ASPIRIN 81 (ACETYLSALICYLIC ACID),UNKNOWN; BENAZEPRIL HCL (BENAZEPRIL HCL),UNKNOWN; CLARITIN ALLERGIC,UNKNOWN; CORTISONE (CORTISONE),UNKNOWN; CRESTOR (ROSUVASTATIN CALCIUM),UNKNOWN; DOC-Q-LACE (DOCUSATE SODIUM),UNKNOWN; FINASTERIDE (FINASTERIDE),UNKNOWN; FLOMAX RELIEF (TAMSULOSIN HYDROCHLORIDE),UNKNOWN; IBUPROFEN (IBUPROFEN),UNKNOWN; IBUPROFEN PM,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; MAGNESIUM (MAGNESIUM),; METHENAMINE HIPPURATE (METHENAMINE HIPPURATE),; PEPCID AC (FAMOTIDINE),; REFRESH EYE ALLERGY RELIEF,UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),; TESTOSTERONE (TESTOSTERONE),
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 136