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 Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This case is cross referenced with case: (b)(4).(cluster).This unsolicited case from united states was received on (b)(6) 2018 from the healthcare professional.This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency had probable pseudo-septic reaction and could not bend it only slightly.Also device malfunction was identified for the reported lot number.The patient had past treatment with atorvastatin calcium (lipitor), multiple vitamins.Patient had responded well to a synvisc-one injection in the past on this left side.No concomitant medication or concurrent condition was provided.The medical history included acl reconstruction (for knee), alcohol use (1 to 2 daily; prior tobacco use) and ringing in ears, known degenerative changes across the patellofemoral joint on the left knee, significant increased discomfort in the anterior aspect of both knees (with the left being worse than the right, increasing discomfort over the superior and lateral aspect of his right shoulder, has been dealing with this for months without any significant relief; he noted it had been exacerbated by certain exercises and particularly if he does a plank with his feet up on a bench or a chair), burning and sharp pain across the anterolateral aspect of his shoulder (he noted no sense of instability nor was there one traumatic event that led to this; was able to continue swimming, but he was aware of the discomfort).He had a family history significant for heart disease on his father's side.The patient did not receive treatment with recreational drugs.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021; expiry date: may-2020) into left knee for left knee pain.The patient's left superolateral knee was prepped using povidone iodine (betadine) and alcohol.A total of 4 cc.Of 1% lidocaine was injected into the subcutaneous tissue down to the level of the joint.This was followed by an aspiration through an 18-gauge needle of drops of benign-appearing synovial fluid.Through the same needle was injected 6 cc.Of synvisc-one.The patient tolerated the injection well and the area was cleaned with alcohol and dressed with a band-aid.On an unknown date in (b)(6) 2017, the patient had a significant swelling after his synvisc-one injection.On an unknown date in (b)(6) 2017, after unknown latency, the patient had a probable pseudo-septic reaction to his synvisc-one injection into this left knee.It was reported that the patient's knee was very stiff.On an unknown date in (b)(6) 2017, the patient could not bend it only slightly and it was very swollen.The patient has no fever.He had a large tensely swollen left knee and it was warm.He had guarded range of motion of about 20 to 80 degrees.Reportedly, the patient was told to ice, use nsaids, ibuprofen at a dose of 800 mg three times a day and watch for calf pain while on the plane.The patient was instructed to go to ed for a venous doppler if calf pain developed.Later, aspiration and possible cortisone injection was discussed with the patient and the patient proceeded with that.Patient's left superolateral knee was prepped using betadine and alcohol.A total of 4 cc.Of 1% lidocaine was injected into the subcutaneous tissue down to the level of the joint.This was followed by an aspiration through an 18-gauge needle of 103 cc.Of inflammatory-appearing fluid.Through the same needle was injected a combination of 4 cc.Of 1% lidocaine, 4 cc.Of 0.25% bupivacaine hydrochloride (marcaine) with epinephrine, and 2 cc.Of triamcinolone acetonide (kenalog).It was reported that the patient tolerated the injection well and the area was cleaned with alcohol and dressed with a band-aid.Reportedly, post-injection the patient noted significant improvement in his symptoms.Corrective treatment: ice; nsaids, ibuprofen triamcinolone acetonide (kenalog) for probable pseudo-septic reaction; not reported for rest of the events outcome: recovering for all the 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 would be completed, corrective and preventive actions would be implemented.Seriousness criteria: required intervention for device malfunction and probable pseudo-septic reaction.Pharmacovigilance comment: sanofi company comment dated 30-jan-2018 this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pesudosepsis.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: 7306594
• MDR Text Key: 101692615
• Report Number: 2246315-2018-00301
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 96