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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Aspiration/Inhalation (1725); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); No Code Available (3191)

Event Type  Injury  

Event Description

Device malfunction [device malfunction].Allergic reactions [hypersensitivity] ([pseudosepsis])."aspitarion" of knee [joint effusion].Case narrative: this case is related to case id.: (b)(4) (cluster case).Initial information received on 29-nov-2018 from united states regarding an unsolicited valid serious case received from a physician.This case involves adult male patient who was in his 60's had experienced allergic reactions, pseudo septic reaction and aspitarion of knee, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc one).Device malfunction was also reported.(latency: unknown).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking synvisc one injection dosage unknown via intra-articular route (lot - 7rsl021, 31-may-2020) for product used for unknown indication.On unknown date, patient experienced allergic reactions in the injection area, almost like pseudoseptic reaction shortly after the injection.Patient also underwent aspirations of knee, culture negative.He also received a steroid injection into that area.Final diagnosis was aspiration of knee, pseudo septic reaction, allergic reactions and device malfunction.Corrective treatment: steroid for allergic reaction, aspiration of knee and pseudo septic reaction.Outcome: recovered for allergic reaction, aspiration of knee and pseudo septic reaction.Seriousness criteria: intervention required for allergic reaction, aspiration of knee, pseudo septic reaction and device malfunction.A product technical complaint was initiated on 30-nov-2018 for synvisc-one.Batch number: 7rsl021 global ptc number: (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 was under investigation.Once this investigation was completed, corrective and preventive actions would be implemented.Information received on 30-nov-2018.Global ptc added.

• 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: 8163904
• MDR Text Key: 130321602
• Report Number: 2246315-2018-00739
• 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
• Reporter Occupation: Physician
• 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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention