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

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); No Code Available (3191)

Event Type  Injury  

Event Description

Bilateral genu varum [genu varum], twisting injury to both knees [twisted knee], synovitis [synovitis], joint has minimal tenderness/ pain in knees [joint tenderness], swelling in knees [knee swelling], mild right knee effusion [effusion (r) knee], moderate left knee effusion [effusion (l) knee].Case narrative: initial information received on 05-dec-2018 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a (b)(6) male patient who had bilateral genu varum, mild right knee effusion, moderate left knee effusion, synovitis (latency: unknown) and twisting injury to both knees (latency: same day).Joint has minimal tenderness/ pain in knees, swelling in knees (latency: 1 day) while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2017, the patient started using hylan g-f 20, sodium hyaluronate injection, dosage unknown, once via intraarticular route (lot - unknown) for end stage osteoarthritis and on same day, patient had twisting injury to the both knees with a near fall and the following day on (b)(6) 2017, 1 day later, patient had marked swelling and pain.This was bit better but had not resolved.On an unknown date.After unknown latency, patient exam shows bilateral genu varum.The joint had minimal tenderness.Patient had mild right and moderate left knee effusion and knees would be "aspirate" for cell count and culture.Patient would be off work for one month.X-ray shows complete loss of medial compartment joint spaces.Corrective treatment: triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic), synovitis for bilateral genu varum, twisting injury to both knees, joint has minimal tenderness/ pain in knees; triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic) and hydrocodone bitartrate, paracetamol (norco) for swelling in knees; triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic) and aspiration done for mild right knee effusion and moderate left knee effusion.Outcome: recovering for swelling in knees and joint has minimal tenderness/ pain in knees; unknown for rest of the events.Seriousness criteria: intervention required for all events.A product technical complaint was initiated and results were pending for the same.

Event Description

Bilateral genu varum [genu varum].Twisting injury to both knees [twisted knee].Synovitis [synovitis].Joint has minimal tenderness/ pain in knees [joint tenderness].Swelling in knees [knee swelling].Mild right knee effusion [effusion (r) knee].Moderate left knee effusion [effusion (l) knee].Case narrative: initial information received on 05-dec-2018 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a 55 years old male patient who had bilateral genu varum, mild right knee effusion, moderate left knee effusion, synovitis (latency: unknown) and twisting injury to both knees (latency: same day), joint has minimal tenderness/ pain in knees, swelling in knees (latency: 1 day) while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On 01-dec-2017, the patient started using hylan g-f 20, sodium hyaluronate injection, dosage unknown, once via intraarticular route (lot - unknown) for end stage osteoarthritis and on same day, patient had twisting injury to the both knees with a near fall and the following day on 02-dec-2017, 1 day later, patient had marked swelling and pain.This was bit better but had not resolved.On an unknown date, after unknown latency, patient exam shows bilateral genu varum.The joint had minimal tenderness.Patient had mild right and moderate left knee effusion and knees would be aspirate for cell count and culture.Patient would be off work for one month.X-ray shows complete loss of medial compartment joint spaces.Corrective treatment: triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic), synovitis for bilateral genu varum, twisting injury to both knees, joint has minimal tenderness/ pain in knees; triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic) and hydrocodone bitartrate, paracetamol (norco) for swelling in knees; triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic) and aspiration done for mild right knee effusion and moderate left knee effusion outcome: recovering for swelling in knees and joint has minimal tenderness/ pain in knees; unknown for rest of the events seriousness criteria: intervention required for all events a product technical complaint (ptc) was initiated on 12-dec-2018 for synvisc one.Batch number: unknown; global ptc number: 56594.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance 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 safety 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 was received on 12-dec-2018.Global ptc number and its results were added.Text amended accordingly.

Event Description

Device malfuction [device malfunction] bilateral genu varum [genu varum] twisting injury to both knees [twisted knee] synovitis [synovitis] joint has minimal tenderness/ pain in knees [joint tenderness] swelling in knees [knee swelling] mild right knee effusion [effusion (r) knee] moderate left knee effusion [effusion (l) knee] case narrative: initial information received on 05-dec-2018 from united states regarding an unsolicited valid serious case received from a lawyer.This case involves a 55 years old male patient who had bilateral genu varum, mild right knee effusion, moderate left knee effusion, synovitis, device malfunction (latency: unknown) and twisting injury to both knees (latency: same day), joint has minimal tenderness/ pain in knees, swelling in knees (latency: 1 day) while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2017, the patient started using hylan g-f 20, sodium hyaluronate injection, dosage unknown, once via intraarticular route (lot -7rsl021; exp.Date: may-2020) for end stage osteoarthritis and on same day, patient had twisting injury to the both knees with a near fall and the following day on (b)(6) 2017 , 1 day later, patient had marked swelling and pain.This was bit better but had not resolved.On an unknown date, after unknown latency, patient exam shows bilateral genu varum.The joint had minimal tenderness.Patient had mild right and moderate left knee effusion and knees would be aspirate for cell count and culture.Patient would be off work for one month.X-ray shows complete loss of medial compartment joint spaces.Corrective treatment: triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic), synovitis for bilateral genu varum, twisting injury to both knees, joint has minimal tenderness/ pain in knees; triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic) and hydrocodone bitartrate, paracetamol (norco) for swelling in knees; triamcinolone acetonide (kenalog) with blood sugar warnings, meloxicam (mobic) and aspiration done for mild right knee effusion and moderate left knee effusion.Outcome: recovering for swelling in knees and joint has minimal tenderness/ pain in knees; unknown for rest of the events.Seriousness criteria: intervention required for all 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.Additional information was received on 12-dec-2018.Global ptc number and its results were added.Text amended accordingly.Additional information was received on 09-jan-2019 from the lawyer.Lot number of suspect product was added.Event of device malfunction was added.Clinical course updated.Text 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: 8163892
• MDR Text Key: 130321333
• Report Number: 2246315-2018-00737
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention