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

Lot Number 7RFL049

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 06/16/2018

Event Type  Injury  

Event Description

Right septic knee/ knee is infected [arthritis septic] ([knee pain], [effusion (r) knee], [haemophilus parainfluenzae infection]).Case narrative: initial information received on 20-jun-2018 from united states regarding an unsolicited valid serious case received from a physician.This case involves a (b)(6) female patient who experienced right septic knee/ knee was infected (latency: 2 days) after receiving injection of hylan g-f 20, sodium hyaluronate (synvisc one).The past medical history, medical treatment(s), vaccination(s) and family history of the patient were not provided.On (b)(6) 2018, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in right knee at 6ml, once for osteoarthritis right knee with lot number 7rfl049 expiry: 31-oct-2020.On (b)(6) 2018, the patient reported to hospital with a lot of pain in knee to the hospital.A complete washout of her knee was done and pus was aspirated from it.On (b)(6) 2018, patient was diagnosed with right septic knee/knee is infected (latency: 2 days).The physician stated that the infectious group at the hospital is worried that the patient may be going into sepsis due to this.The preliminary culture from the patient's knee revealed scant gram negative coccobacilli.It was further reported that patient had not received any synvisc one injections before.The physician further reported that they have pulled off the product from the shelf because of the immediate reaction the patient had.At the time of this report, patient was still hospitalized.As of (b)(6) 2018, it was reported that the health care professional isolated haemophilus parainfluenzae.No further information was provided.Corrective treatment: not reported.Outcome: not recovered/not resolved.A product technical complaint had been initiated and the results were pending for the same.Seriousness criterion: medically significant and hospitalization.A product technical complaint (ptc) was initiated on (b)(6) 2018 for "synvisc one".Batch number unknown, global ptc number: (b)(4).The reporter stated that the device caused "right septic knee, lot of pain in knee, aspirated pus from her knee, scant gram negative coccobacilli" that resulted in "arthritis bacterial, arthralgia, joint effusion and haemophilus infection".The production and quality control documentation for lot 7rsl049 expiration date (31-oct-2020) was reviewed.The investigation showed that the product met specifications.No associated non -conformances were noted.Based on batch record review and frequency analysis for lot 7rsl049 no capa was required.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 06-jul-2018.No safety issues were indicated in this review.Additional information was received on (b)(6) 2018 from a physician.The symptom term scant gram negative coccobacilli was updated to scant gram negative coccobacilli/ isolated haemophilus parainfluenzae.Clinical course was updated and text was amended accordingly.Additional information was received on (b)(6) 2018 in the form of investigation summary.Gptc number and ptc results were added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8398731
• MDR Text Key: 138102138
• Report Number: 2246315-2018-00873
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Lot Number: 7RFL049
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR