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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

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

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Septic arthritis [septic arthritis] ([joint inflammation], [joint swelling], [joint infection], [joint effusion], [popliteal cyst], [cellulitis]).Patellofemoral and medial compartment arthrosis [arthrosis] ([condition aggravated]) acute right knee pain [knee pain].Hematocrit low [hematocrit low].Case narrative: initial information received from united states on 09-nov-2018 regarding an unsolicited valid serious case received from a lawyer suite.This case involves a (b)(6) years old male patient who experienced septic arthritis, device malfunction, acute right knee pain and hematocrit low, while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).(latency: unknown).The patient's past medical history included arthritis, arthroscopy on (b)(6) 2017, joint surgery, peripheral swelling, meniscus injury and chondromalacia.His family history included neoplasm malignant and it was unspecified who suffered from it.His past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing alcohol use with alcohol use (current some day).On (b)(6) 2017, the patient started using synvisc one injection dosage 6 ml once (lot - 7rsl021, 31-may-2020) for right knee pain, patellofemoral arthritis and osteoarthritis.On (b)(6) 2018, patient went to hospital and it was observed that patient experienced acute right knee pain and cellulitis.On the (b)(6) 2018, patient presented in the medical facility with infection, redness and swelling.It was also observed that there was small effusion and small amount of fluid in the medial gastrocnemicus-semimembranosus bursa (small popliteal cyst measured about 4 cm).Septic arthritis was concluded by observing these symptoms.It was also concluded during by the examination of that day patient also suffered from patellofemoral and medial compartment arthrosis.Therefore, patient underwent for right knee arthroscopy, arthroscopic partial medial meniscectomy, arthroscopic partial lateral meniscectomy and arthroscopic patellofemoral chondroplasty.On the same day, patient underwent lab analysis, hematocrit was found 41.8 (low) (range-42.0-52.0).Final diagnosis was hematocrit low, acute right knee pain, device malfunction and septic arthritis.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: naproxen, medrol, diclofenac sodium for acute right knee pain; cephalexin for septic arthritis.Outcome: unknown for all the events.Seriousness criteria: medically significant for septic arthritis; interventional required for patellofemoral and medial compartment arthrosis and acute right knee pain.Follow up information received on 15-nov-2018.Global ptc number added.No significant information was received.Follow up information received on 20-nov-2018.No new information was received.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8111097
• MDR Text Key: 128617600
• Report Number: 2246315-2018-00712
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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