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

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Bacterial Infection (1735); Erythema (1840); Joint Swelling (2356); No Code Available (3191)

Event Date 11/13/2017

Event Type  Injury  

Event Description

Fluid drawn from the knee and analyzed which was positive for infection [joint infection] ([knee swelling], [redness], [joint inflammation], [joint warmth], [joint effusion], [device malfunction]); achilles tear [achilles tendon rupture]; difficulty bearing weight [weight bearing difficulty] ; issues with one of her eyes, possibly a growth over the eye that is obstructing her vision [eye disorder].Case narrative: this case is related to case id.: (b)(4) (duplicate case.) initial information received on (b)(6) 2018 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study " (b)(4)".Patient id: (b)(6); country: united states study title sanofi patient connection.This case involves a (b)(6) female patient who experienced achilles tear, issues with one of her eyes, possibly a growth over the eye that is obstructing her vision, fluid drawn from the knee and analyzed which was positive for infection, device malfunction and difficulty bearing weight after using medical device hylan g-f 20, sodium hyaluronate (synvisc one).(latency: unknown) the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2017, patient was administered synvisc one injection intra-articularly of 6 ml dosage in the left leg (lot 7rsl021, expiration date: 31-may-2020).Shortly after the injection was received, patient experienced swelling, redness, warmth and inflammation in the affected knee (latency: same day).It was reported that the patient wore a knee brace after she had the injection, prior to that she was not using any ambulatory device.On (b)(6) 2017 patient received a letter stating that there was a synvisc one recall.On an unknown date in (b)(6) 2018, patient experienced achilles tear which the hcp believed was due to wearing the knee brace(latency: 1 year ).On (b)(6) 2018, patient underwent surgery for achilles tear.On an unknown date, patient had fluid drawn off from the knee and analyzed which was positive for infection.The type of infection was unknown to the patient and she was treated with antibiotics for the same.Also, patient had difficulty bearing weight on the affected knee for an unknown period of time (latencies: unknown).On an unknown date, patient experienced issues with one of her eyes, possibly a growth over her eye that is obstructing her vision.(latency: unknown).Patient saw an optometrist on (b)(6) 2018 and had been scheduled to see the specialist on (b)(6) 2018 so that the growth over the eye can be removed.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.Final diagnosis was achilles tear, issues with one of her eyes, possibly a growth over the eye that is obstructing her vision, fluid drawn from the knee and analyzed which was positive for infection and difficulty weight bearing in the affected knee treatment: antibiotics for fluid drawn from the knee and analyzed which was positive for infection, bloodwork to measure white and red blood cell counts, wearing a brace fluid drawn from the knee and analyzed which was positive for infection.Surgery for achilles tendon outcome: not recovered for achilles tendon and issues with one of her eyes, possibly a growth over the eye; unknown for weight bearing difficulty.Seriousness criteria: intervention required for achilles tear; medically significant and disability for fluid drawn from the knee and analyzed which was positive for infection.Reporter causality: not reported for all events company causality: not reportable for issues with one of her eye, possibly a growth over the eye, achillies tear; reportable for rest of the events.Follow up information received on 27-aug-2018 in the form of investigation summary.No new information was received.

• 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: 7927917
• MDR Text Key: 122631330
• Report Number: 2246315-2018-00649
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,study
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• 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): Other; Required Intervention; Disability
• Patient Age: 67 YR