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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Erythema (1840); Dizziness (2194); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/14/2017

Event Type  malfunction  

Event Description

Device malfunction [device malfunction] ; redness [localized erythema] ; dizziness [dizziness] ; pain/extreme pain [knee pain] ; swelling [knee swelling].Case narrative: upon internal review on (b)(6) 2018: this case was identified as a duplicate of (b)(4).All the information of this case has been merged in to the case (b)(4).This case has been prepared for deletion.Based on the information received on (b)(6) 2018 the case initially processed as non-serious has been updated to serious because of addition of a medically significant event of device malfunction.This case is cross referred to (b)(4) (duplicate).This unsolicited case from united states was received on (b)(6) 2018 from a patient.This case concerns a (b)(6) male patient who experienced pain/ extreme pain, swelling , redness and dizziness (latency: same day) receiving treatment with synvisc one.Also there was a device malfunction.No relevant past drugs, concomitant medication or concurrent condition was provided.Medical history included hypertension, seasonal allergies, gerd (gastroesophageal reflux disease) and osteoarthritis.The patient had no prosthetic hip/knee, prosthetic valve, pacemaker or defibrillator, no allergy history on (b)(6) 2017, the patient-initiated treatment with intra-articular synvisc one injection (batch/lot number: 7rsl021 and expiry date: not provided) single dose for knee pain.On an the same day after receiving injection the patient had some extreme pain, swelling , redness and dizziness.On (b)(6) 2017, the patient stopped taking synvisc injection.The patient problems partially went away after the synvisc one was stopped.Corrective treatment: none for all events.Outcome: not recovered for all events.Seriousness criteria: medically significant for device malfunction.A product technical complaint (ptc) was initiated for synvisc one; batch number: 7rsl021, global ptc number: unknown.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 14-mar-2018.Ptc (pharmaceutical technical complaint) results were added.Text was amended accordingly.Additional information was received on (b)(6) 2018 from the patient.Medical history of osteoarthritis was added.Upon internal review investigation summary was removed from the case.Text was amended accordingly.Additional information was received on 06-sep-2018.Global ptc results were added.Clinical course updated.Text amended accordingly.Upon internal review on 29-nov-2018: this case was identified as a duplicate of (b)(4).All the documents of this case has been merged in to the case (b)(4).This case has been prepared for deletion.

• 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: 8163905
• MDR Text Key: 131768239
• Report Number: 2246315-2018-00738
• 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: 12/14/2018

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 Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2018
• 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
• Patient Age: 76 YR
• Patient Weight: 90