MAUDE Adverse Event Report: SYNVISC; MOZ

Lot Number UNKNOWN

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

Patient Problems Fall (1848); Hypoesthesia (2352); Arthralgia (2355); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Sanofi company follow up comment dated 23-jan-2019:follow up information does not change previous case assessment.This case concerns a patient who was on treatment with hylan g-f 20, sodium hyaluronate (synvisc) and required intervention for joint noise, arthralgia and knee effusion.There is no evidence of the event to occur with device.Therefore, the role of device cannot be established.Further, detailed information regarding clinical course of the events would aid in better assessment of the case.

Event Description

2+ crepitus with popping [joint crepitation].Tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing [joint tenderness] ([condition aggravated]).1+ effusion [effusion (r) knee].Slipped and fell [fall].Decreased sensation along the lateral aspect of the leg and dorsum of the foot [numbness in leg].Case narrative: initial information received on 17-jan-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "(b)(6)".Patient id: (b)(6); country: united states.Study title: sanofi patient connection.This case involves a (b)(6) years old male patient who had treatment with hylan g-f 20, sodium hyaluronate (synvisc) and after unknown latency experienced 2+ crepitus with popping, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and slipped and fell, 1+ effusion, decreased sensation along the lateral aspect of the leg and dorsum of the foot.The patient's past medical history included post right partial medial and lateral meniscectomy, post chondroplasty right patella and excision patella fracture fragment, debridement right acl tear and partial synovectomy, post lateral retinacular release.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing varicose vein in knee (bilateral right greater than left) and wears support hose, was a knee brace user and right medial compartment osteoarthritis.Concomitant medications included chondroitin sulfate, glucosamine sulfate (glucosamine chondroitin sulfate).On an unknown date in 2017, the patient started taking hylan g-f 20, sodium hyaluronate intra-articular injection once x 3 weeks (with an unknown batch number) for unknown indication.On (b)(6) 2018, patient slipped and fell at work, sent to auc, seen and released.On (b)(6) 2018, patient complained that pain was 1 out of 10 and was interested in a steroid injection.Patient claimed that the hylan g-f 20, sodium hyaluronate really helped.Patient stated that the knee brace had worn out and he was wearing support hose for the varicose veins.Patient said that currently the pain was worse at night.Right knee exam showed active range of motion of 0-125, incision were healed well.Patient had 1+ effusion, had no medial or lateral; instability at zero or 30 but had pain on valgus stressing, 1+ anterior drawer, tender along medial joint line, 2+ crepitus with popping and media facet tenderness, negative homans test, decreased sensation along the lateral aspect of the leg and dorsum of the foot.The patient had good distal pulses and no new skin lesions.The patient was given a steroid injection, given a new knee brace as old one was worn out.Patient was recommended neurontin and to repeat hylan g-f 20, sodium hyaluronate injections.Final diagnosis was slipped and fell, tender along medial joint line/media facet tenderness/recurrent right knee pain and 2+ crepitus with popping.Action taken: unknown.Corrective treatment: methylprednisolone acetate (depomedrol) and ice for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping, not reported for rest.Outcome: unknown for all events.Seriousness criteria: intervention required for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping.Reporter causality: unassessable (unknown) for all events.Company causality: not reportable for all events.A product technical complaint was initiated on (b)(6) 2019 for synvisc.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 was 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 did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information received on 23-jan-2019.Investigation summary received and ptc results added.Clinical course updated.Text amended accordingly.

Manufacturer Narrative

Sanofi company follow up comment dated (b)(6) 2019.Follow up information does not change previous case assessment.This case concerns a 59 years old male patient who developed 2+ crepitus with popping while on treatment with hylan g-f 20, sodium hyaluronate (synvisc).Although the role of drug cannot be denied for the event; however medical history of post right partial medial and lateral meniscectomy, post chondroplasty right patella, excision patella fracture fragment, debridement right acl tear, partial synovectomy; concurrent conditions of varicose vein in knee and right medial compartment osteoarthritis are confounding factors for the same.Moreover, the role of concomitant medications cannot be underestimated either.

Event Description

2+ crepitus with popping [joint crepitation] tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing [joint tenderness] ([condition aggravated]) 1+ effusion [effusion (r) knee] decreased sensation along the lateral aspect of the leg and dorsum of the foot [numbness in leg] slipped and fell [fall] case narrative: initial information received on 17-jan-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6), country: united states.Study title: sanofi patient connection.This case involves a 59 years old male patient who had treatment with hylan g-f 20, sodium hyaluronate (synvisc) and after unknown latency experienced 2+ crepitus with popping, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and slipped and fell, 1+ effusion, decreased sensation along the lateral aspect of the leg and dorsum of the foot.The patient's past medical history included post right partial medial and lateral meniscectomy, post chondroplasty right patella and excision patella fracture fragment, debridement right acl tear and partial synovectomy, post lateral retinacular release.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing varicose vein in knee (bilateral right greater than left) and wears support hose, was a knee brace user and right medial compartment osteoarthritis.Concomitant medications included chondroitin sulfate, glucosamine sulfate (glucosamine chondroitin sulfate).On an unknown date in 2017, the patient started taking hylan g-f 20, sodium hyaluronate intra-articular injection once x 3 weeks (with an unknown batch number) for unknown indication.On (b)(6) 2018, patient slipped and fell at work, sent to auc, seen and released.On (b)(6) 2018, patient complained that pain was 1 out of 10 and was interested in a steroid injection.Patient claimed that the hylan g-f 20, sodium hyaluronate really helped.Patient stated that the knee brace had worn out and he was wearing support hose for the varicose veins.Patient said that currently the pain was worse at night.Right knee exam showed active range of motion of 0-125, incision were healed well.Patient had 1+ effusion, had no medial or lateral; instability at zero or 30 but had pain on valgus stressing, 1+ anterior drawer, tender along medial joint line, 2+ crepitus with popping and media facet tenderness, negative homans test, decreased sensation along the lateral aspect of the leg and dorsum of the foot.The patient had good distal pulses and no new skin lesions.The patient was given a steroid injection, given a new knee brace as old one was worn out.Patient was recommended neurontin and to repeat hylan g-f 20, sodium hyaluronate injections.On (b)(6) 2019, the physician reported that the event of fall had nothing to do with the hylan g-f 20, sodium hyaluronate injection the patient received.The physician further reported that the patient had received hylan g-f 20, sodium hyaluronate injection a few months prior to the fall.Action taken: unknown.Corrective treatment: methylprednisolone acetate (depomedrol) and ice for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping, not reported for rest outcome: unknown for all events.A product technical complaint was initiated on (b)(6) 2019 for synvisc.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 was 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 did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required seriousness criteria: intervention required for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping.Reporter causality: not related for slipped and fell; unknown (un-assessable) for rest.Company causality: not reportable for all events.Additional information received on 23-jan-2019.Investigation summary received and ptc results added.Clinical course updated.Text amended accordingly.Additional information received on 02-apr-2019 from physician.Event details pertaining to slipped and fell added.Clinical course updated.Corresponding field and narrative were amended accordingly.Follow up information received on 05-apr-2019 from patient.No new information received.

Manufacturer Narrative

Sanofi company follow up comment dated (b)(6) 2019:follow up information does not change previous case assessment.This case concerns a patient who was on treatment with hylan g-f 20, sodium hyaluronate (synvisc) and required intervention for joint noise, arthralgia and knee effusion.There is no evidence of the event to occur with device.Therefore, the role of device cannot be established.Further, detailed information regarding clinical course of the events would aid in better assessment of the case.

Event Description

2+ crepitus with popping [joint crepitation] tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing [joint tenderness] ([condition aggravated]) 1+ effusion [effusion (r) knee] slipped and fell [fall] decreased sensation along the lateral aspect of the leg and dorsum of the foot [numbness in leg] case narrative: initial information received on 17-jan-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6), country: united states.Study title: sanofi patient connection.This case involves a 59 years old male patient who had treatment with hylan g-f 20, sodium hyaluronate (synvisc) and after unknown latency experienced 2+ crepitus with popping, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and slipped and fell, 1+ effusion, decreased sensation along the lateral aspect of the leg and dorsum of the foot.The patient's past medical history included post right partial medial and lateral meniscectomy, post chondroplasty right patella and excision patella fracture fragment, debridement right acl tear and partial synovectomy, post lateral retinacular release.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing varicose vein in knee (bilateral right greater than left) and wears support hose, was a knee brace user and right medial compartment osteoarthritis.Concomitant medications included chondroitin sulfate, glucosamine sulfate (glucosamine chondroitin sulfate).On an unknown date in 2017, the patient started taking hylan g-f 20, sodium hyaluronate intra-articular injection once x 3 weeks (with an unknown batch number) for unknown indication.On(b)(6) 2018, patient slipped and fell at work, sent to auc, seen and released.On (b)(6) 2018, patient complained that pain was 1 out of 10 and was interested in a steroid injection.Patient claimed that the hylan g-f 20, sodium hyaluronate really helped.Patient stated that the knee brace had worn out and he was wearing support hose for the varicose veins.Patient said that currently the pain was worse at night.Right knee exam showed active range of motion of 0-125, incision were healed well.Patient had 1+ effusion, had no medial or lateral; instability at zero or 30 but had pain on valgus stressing, 1+ anterior drawer, tender along medial joint line, 2+ crepitus with popping and media facet tenderness, negative homans test, decreased sensation along the lateral aspect of the leg and dorsum of the foot.The patient had good distal pulses and no new skin lesions.The patient was given a steroid injection, given a new knee brace as old one was worn out.Patient was recommended neurontin and to repeat hylan g-f 20, sodium hyaluronate injections.Final diagnosis was slipped and fell, tender along medial joint line/media facet tenderness/recurrent right knee pain and 2+ crepitus with popping.Action taken: unknown.Corrective treatment: methylprednisolone acetate (depomedrol) and ice for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping, not reported for rest outcome: unknown for all events.Seriousness criteria: intervention required for 1+ effusion, tender along medial joint line/media facet tenderness/recurrent right knee pain/pain on valgus stressing and 2+ crepitus with popping.Reporter causality: unassessable (unknown) for all events.Company causality: not reportable for all events.A product technical complaint was initiated on (b)(6) 2019 for synvisc.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 was 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 did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required additional information received on 23-jan-2019.Investigation summary received and ptc results added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• MDR Report Key: 8291166
• MDR Text Key: 134568922
• Report Number: 2246315-2019-00033
• 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: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2019; 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GLUCOSAMINE CHONDROITIN SULFATE,UNKNOWN; GLUCOSAMINE CHONDROITIN SULFATE,UNKNOWN; GLUCOSAMINE CHONDROITIN SULFATE,UNKNOWN
• Patient Outcome(s): Required Intervention