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 Arthralgia (2355); Joint Swelling (2356)

Event Type  malfunction  

Event Description

This case is cross-referred to case id: (b)(4) (cluster) this unsolicited case from united states was received on (b)(6) 2018 from a physician.This case concerns a 3 patients (demographics: not provided) who received treatment with synvisc one injection and later after unknown latency developed pain and swelling in the knee.Also, device malfunction was identified for the reported lot number.No relevant past drug, medical history, concomitant medications and concurrent conditions were reported.On an unknown date in (b)(6) 2017, the patients initiated treatment with intra- articular synvisc one injection (dose, frequency, indication: not provided; batch/lot: 7rsl021 and expiration date: not provided).On an unspecified date, after unknown latency, the patients complained of pain and swelling in the knee.All three patients received corticosteroids as treatment.It was reported that three patients have responded to the corticosteroids.It was unknown whether patient received any other injections prior to treatment.Patients was seen two days after the injection and was for complaints of pain and swelling.It was unknown if the patient engaged in any activities such as tennis or jogging soon after the injection.Patients were known to have pain and swelling in the affected knee.Measurements of the knee circumference was not known.It was unknown if the patients were able to bear weight before and after the injection.It was unknown as the level of pain that the patients complained of.It was unknown if the patients had a fever.Blood work were done but, results and specific type of lab work completed was unknown.Cultures were completed but, results of culture were unknown.The patients had been treated with corticosteroids.The patient had not been hospitalized but, stated that the providers office noted that the patient may require surgery on the knee as a result of the injection.The three of the patients had recovered.Action taken: unknown corrective treatment: corticosteroids for pain and swelling in the knee outcome: recovered for all the events seriousness criteria: required intervention 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 is completed, corrective and preventive actions would be implemented.

• 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: 7288210
• MDR Text Key: 101025177
• Report Number: 2246315-2018-00330
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/09/2018

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?: No
• Device Operator: Other
• Device Lot Number: 7RSL021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 02/22/2018
• 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): Required Intervention