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

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)

Event Type  malfunction  

Event Description

Based on information received on 24-apr-2018, the report previously considered as non-valid became valid as the additional events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added. Additionally, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction was added). This unsolicited case from united states was received on 23-jan-2018 from patient. This case concerns a (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency, could not bend, severe pain in knee/ pain significantly worse after reaction and had significant swelling in knee and also had issue on long term basis since receiving synvisc-one. Additionally, the device malfunction was reported for the lot number used. No previous medications, medical history, concomitant medications and concurrent conditions were reported. It was reported that the patient was allergic to penicillin. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 1 df once for osteoarthritis (batch/ lot number: 7rsl021 and expiry date: unknown). Patient had been experiencing issue on long term basis since receiving synvisc one. On unknown dates, the patient experienced severe pain and significant swelling in the knee and the patient could not bend it. The patient reported that the pain was significantly worse after the injection than prior to the injection. On (b)(6) 2017 and (b)(6) 2018, the patient consulted the health professional. At the time of report on (b)(6) 2018, the patient still had these problems. Corrective treatment: not reported for all the events outcome: not recovered for all events a product technical complaint was initiated with (b)(4). 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: important medical event for device malfunction. Additional information was received on 07-feb-2018. Investigation summary results and global ptc number were added. Clinical course was updated and text was amended accordingly. Additional information was received on 24-apr-2018 from the patient. The patient's date of birth, age and height were added. The events of device malfunction, could not bend, severe pain in knee/ pain significantly worse after reaction and significant swelling in knee were added along with the details. Clinical course was updated and 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 ; 9089817289
• MDR Report Key: 7487586
• MDR Text Key: 107384676
• Report Number: 2246315-2018-00471
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/24/2018
• 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 Treatment Data

Date Received: 05/04/2018 Patient Sequence Number: 1