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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/15/2017

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Antalgic gait [antalgic gait].Swelling [swelling of r knee].Warmth to knee [joint warmth].Large effusion [effusion (r) knee].Pain with knot at the knee [knee pain].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This case is cross referenced with cases: 2018sa019118, 2018sa019063 and 2018sa018127 (cluster).This unsolicited case was received on 05-jan-2018 from a pharmacist via health authority of united states (usfda with regulatory reference number: (b)(4)).This case involves a patient of unknown demographics age who received treatment with synvisc one and later after one day had swelling, warmth to knee, pain with knot at the knee; after unknown latency had large effusion and antalgic gait.Also, device malfunction was identified for the reported lot number.No medical history, past drugs, concomitant medications or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at dose of 6 ml once (batch number: 7rsl021 and expiration date: 31- may-2020) for osteoarthritis of knee.On 15-nov-2017, one day after receiving injection, patient reported: continued pain with "knot" at the knee.Patient was recommended rest, ice, and otc (over the counter) pain medications (tylenol/ibuprofen).It was reported that patient had worsening symptoms: swelling and warmth to knee.Patient follow up visit scheduled at clinic.On an unknown date, latency unknown, doctor noted: markedly antalgic gait, large effusion, and mild warmth of right knee.It was reported that the 85 ml of cloudy fluid aspirated and patient received injection of 3ml of 1 percent lidocaine and 80 mg of methylprednisolone.Patient reported improved symptoms.On follow up visit, patient improved with plans to proceed with right total knee arthroplasty.Corrective treatment: rest, ice, tylenol/ibuprofen, lidocaine, methylprednisolone for pain with knot at the knee; 85ml of cloudy fluid aspirated, lidocaine, methylprednisolone for large effusion and swelling; lidocaine, methylprednisolone for warmth to knee; not reported for rest events.Outcome: recovering 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: medically significant for antalgic gait, swelling, warmth to knee, large effusion, pain with knot at the knee; required intervention for swelling, warmth to knee, large effusion, pain with knot at the knee.Pharmacovigilance comment: sanofi company comment dated 30-jan-2018: this case concerns a patient who received right intra-articular synvisc one injection from the recalled lot and had antalgic gait later with increased knee pain, swelling, effusion and warmth.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.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 10453920
• MDR Text Key: 213235286
• Report Number: 2246315-2020-00110
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/26/2020

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?: Yes
• Device Operator: No Information
• 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: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention