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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Reaction, Injection Site (2442); Skin Inflammation (2443)

Event Date 11/08/2017

Event Type  malfunction  

Event Description

This case was cross reference with (b)(4) (cluster) this unsolicited case from united states was received on 28-feb-2018 from other health care professional.This case concerns a patient (age and gender unspecified) who received treatment with synvisc one and after two days patient had difficult to bend the knee, right knee was very painful/ sore to touch above the knee and right under the knee, right knee was swollen and knee feels tight.Also, device malfunction was identified for the reported lot number.No medical history, past drug, concomitant medication or concurrent condition was provided.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, one dosage form once (batch/lot number: 7rsl021; indication and expiry date: not reported) bilaterally.On (b)(6) 2017, after two days of receiving injection, patient called the office and stated right knee was very painful and swollen and left knee was fine.Patient very difficult to bend the knee, felt tight and very sore to touch above the knee and right under the knee.On (b)(6) 2017, doctor saw patient on urgent basis and ran a musculoskeletal ultra sound probe over the knees.Doctor saw a small amount of fluid but thought it was interstitial fluid and thickening rather than a pocket of fluid that could be aspirated.Corrective treatment: not reported for all events.Outcome: unknown for all events.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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 8-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced joint range of motion decreased, right knee pain, swelling and tightness.A temporal relationship can be established with the product administration.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product 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: 7334127
• MDR Text Key: 102457558
• Report Number: 2246315-2018-00385
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• 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): Other