MAUDE Adverse Event Report: GENZYME BIOSURGERY (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 Type  Injury  

Event Description

Major swelling [knee swelling], had to call out of work the next day [inability to work], pain [knee pain], device malfunction [device malfunction], possible sore throat but isn't positive [sore throat].Case narrative: initial information received on 05-jun-2018 regarding an unsolicited valid serious case received from the patient.Country: united states this case involves a (b)(6) male patient of (b)(6) who experienced major swelling, had to call out of work the next day, pain, device malfunction and possible sore throat (latency: unknown) while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment, vaccination and family history were not provided.In (b)(6) 2018, the patient took synvisc one dosage unknown (batch/lot number: 7rsl021; expiry date: unknown) in his left knee for product used for unknown indication.On the night of receiving his injection, patient developed major swelling (latency: unknown) which persisted for several days and lasted into weekend.It was reported that the patient had to call out of work the next day due to the swelling (latency: unknown).Also, the patient reported that his pain (latency: unknown) improved after his swelling went down.Patient had taken advil to help with the swelling but did not visit the hospital or the doctor's office for follow up.It was reported that the patient had a steroid injection and he did not do any walking or heavy lifting post synvisc-one injection.Patient also reported that he may had a possible sore throat but he wasn't positive (latency: unknown).Event of device malfunction (latency: unknown) was also reported since the synvisc one injection was from the recalled lot.It was reported by the patient that the knee that was injected with the synvisc-one contains hardware and whether he should be concerned.Final diagnosis was pain, possible sore throat but isn't positive, had to call out of work the next day, device malfunction and major swelling.A product technical complaint was initiated on 14-jun-2018 for synvisc one, batch number: 7rsl021, (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labeled 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.The patient outcome is reported as recovered/resolved for swelling.Recovering/resolving for pain.Unknown for had to call out of work the next day, device malfunction and possible sore throat but isn't positive.Follow up information received on 05-jun-2018 from patient.Consumer reported that the knee that was injected with synvisc-one contains hardware.Clinical course updated.Text amended accordingly.Additional information was received on 14-jun-2018.The global ptc number was added.Text was amended accordingly.

• 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: 7925459
• MDR Text Key: 122310410
• Report Number: 2246315-2018-00623
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Weight: 185