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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303); Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 02-oct-2018.Patient experienced right knee pain after receiving treatment with synvisc-one and had to use cane/crutch.A temporal relationship can be established with the product administration.Based on limited information provided, causal role of suspect product cannot be excluded.Case will be re-evaluated post further update on the patients underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Right knee pain/tenderness about the medial joint line [knee pain].Low-grade temperature [body temperature decreased].Mild crepitation [joint crepitation].Shot had not worked out well [device ineffective].Swelling at the injection [injection site swelling].Case narrative: initial information received on 02-oct-2018 from united states regarding a legal unsolicited valid serious case received from physician.This case involves a (b)(6) years old male patient ((b)(6)) who experienced right knee pain/ tenderness about the medial joint line, swelling at the injection, low-grade fever, mild crepitation and shot had not worked out well after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included muscle spasms in back and former smoker.The patient's past surgical history included meniscus surgery and arthroscopic surgery.The patient drinks alcohol.No relevant family history.The past medical treatment(s), vaccination(s) were not provided.Concomitant medication included soma.On (b)(6) 2017 patient received intra-articular injection of synvisc one (hylan g-f 20, sodium) at dosage 6ml 1x (lot number: unknown) for right knee pain secondary to osteoarthritis.The site was prepped sterile with betadine.A 22-gauge one half inch needle was inserted into the joint via anterolateral approach and 6ml of synvisc-one was injected.The patient tolerated the procedure well.On (b)(6) 2017, the patient reported to the clinic at the request of the physician as the physician believed the patient received synvisc one injection from the recall lot.The patient complained of right knee pain (latency: same day) and swelling at the injection (latency: same day) immediately after having received the synvisc-one injection which persisted for a few days.The patient also had low-grade temperature (latency: few days).Patient stated that the shot had not worked out well (latency: same day).As a corrective, patient received ibuprofen, tylenol for pain and also used a cane/crutch.He further reported that the swelling had resolved and he had no recent fevers.Further upon examination it was found that the knee had mild crepitation (latency: 16 days) and tenderness about the medial joint line was noticed.Corrective treatment: tylenol, ibuprofen and cane/crutch for right knee pain/ tenderness about the medial joint line; not reported for rest.Outcome: recovered/resolved for swelling, low grade temperature; recovering/resolving for right knee pain/ tenderness about the medial joint line; unknown for rest.Seriousness criterion: disability for right knee pain/ tenderness about the medial joint line.A product technical complaint was initiated and results are pending for the same.

Event Description

Device malfunction [device malfunction].Right knee pain/tenderness about the medial joint line [knee pain].Low-grade temperature [body temperature decreased].Mild crepitation [joint crepitation].Shot had not worked out well [device ineffective].Swelling at the injection [injection site swelling].Case narrative: initial information received on 02-oct-2018 from united states regarding a legal unsolicited valid serious case received from lawyer.This case involves a 62 years old male patient (167 cm and 88.435 kg) who experienced right knee pain/ tenderness about the medial joint line, swelling at the injection, low-grade fever, mild crepitation, shot had not worked out well after receiving treatment with hylan g-f 20, sodium hyaluronate (synvisc one).Also device malfunction was reported for this lot number.The patient's past medical history included muscle spasms in back and former smoker.The patient's past surgical history included meniscus surgery and arthroscopic surgery.The patient drinks alcohol.No relevant family history.The past medical treatment(s), vaccination(s) were not provided.Concomitant medication included soma.On (b)(6) 2017 patient received intra-articular injection of synvisc one (hylan g-f 20, sodium) at dosage 6ml 1x (lot number: 7rsl021; exp.Date: 31-may-2020) for right knee pain secondary to osteoarthritis.The site was prepped sterile with betadine.A 22-gauge one half inch needle was inserted into the joint via anterolateral approach and 6ml of synvisc-one was injected.The patient tolerated the procedure well.On (b)(6) 2017 , the patient reported to the clinic at the request of the physician as the physician believed the patient received synvisc one injection from the recall lot.The patient complained of right knee pain (latency: same day) and swelling at the injection (latency: same day) immediately after having received the synvisc-one injection which persisted for a few days.The patient also had low-grade temperature (latency: few days).Patient stated that the shot had not worked out well (latency: same day).As a corrective, patient received ibuprofen, tylenol for pain and also used a cane/crutch.He further reported that the swelling had resolved, and he had no recent fevers.Further upon examination it was found that the knee had mild crepitation (latency: 16 days) and tenderness about the medial joint line was noticed.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.Corrective treatment: tylenol, ibuprofen and cane/crutch for right knee pain/ tenderness about the medial joint line; not reported for rest of the events.Outcome: recovered/resolved for swelling, low grade temperature; recovering/resolving for right knee pain/ tenderness about the medial joint line, device malfunction; unknown for rest.Seriousness criterion: disability for right knee pain/ tenderness about the medial joint line and device malfunction.Additional information was received on 12-dec-2018 from the lawyer.Suspect product lot number 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: 7947429
• MDR Text Key: 123195981
• Report Number: 2246315-2018-00672
• Device Sequence Number: 0
• Product Code: MOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOMA (CARISOPRODOL),; SOMA (CARISOPRODOL),
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Weight: 88