MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Arthralgia (2355); Joint Swelling (2356)

Event Date 11/01/2017

Event Type  Injury  

Event Description

This case was cross reference with case ids: 2017sa242214, 2017sa242220, 2017sa242222, 2017sa242223, 2017sa242224, 2017sa242225, 2017sa242226, 2017sa242221 and 2017sa242228 (cluster).This unsolicited case from united states was received on (b)(6) 2017 from other non-health care professional this case concerns a male patient (age unspecified) who received treatment with synvisc one and after an unknown latency had red knee, knee effusion, painful knee and swollen knee.No past drugs, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (frequency, dose, indication: not reported; lot number: 7rsl021 and expiration date: may-2020).On an unknown date in nov- 2017, after unknown latency, patient had knee effusions, with similar symptoms of red, swollen and painful.It was reported that the patient had emergency room visit and hospitalization occurred on (b)(6) 2017.Action taken: unknown.Corrective treatment: not reported for all events.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: hospitalization for all events.

Event Description

This case was cross reference with case ids: (b)(4) (cluster).This unsolicited case from united states was received on 28-nov-2017 from other non-health care professional this case concerns a male patient (age unspecified) who received treatment with synvisc one and after an unknown latency had red knee, knee effusion, painful knee, swollen knee and device malfunction was identified for the reported lot number no past drugs, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (frequency, dose, indication: not reported; lot number: 7rsl021 and expiration date: may-2020).On an unknown date in (b)(6) 2017, after unknown latency, patient had knee effusions, with similar symptoms of red, swollen and painful.It was reported that the patient had emergency room visit and hospitalization occurred on (b)(6) 2017.Action taken: unknown.Corrective treatment: not reported for all events.Outcome: unknown for all events.A pharmaceutical technical complaint was initiated with 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 would be completed, corrective and preventive actions would be implemented.Seriousness criterion: hospitalization for all events additional information was received on 28-nov-2017 and 16-dec-2017 (processed together with clock start date of 28-nov-2017).Additional event of device malfunction was added with details.Global ptc number was (b)(4) added.Ptc results were added.Clinical course updated and text was amended accordingly pharmacovigilance comment: sanofi company comment for follow-up dated 28-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and had red knee, knee effusion, painful knee and swollen knee.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7096346
• MDR Text Key: 94146080
• Report Number: 2246315-2017-00230
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: Physician
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization