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

Lot Number 7RSL021

Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)

Patient Problems Inflammation (1932); Reaction (2414)

Event Type  malfunction  

Event Description

Based upon additional information received on 22-nov- 2017, the case initially assessed as non-serious was upgraded to serious as the serious event device malfunction with the seriousness criterion of important medical event was added.This case is cross referenced with case: (b)(4) (cluster).This unsolicited case from united states was received on 21-nov-2017 from a non-healthcare professional.This case concerns a patient of unknown demographics who received treatment with synvisc one and later after unknown latency had flare-up/inflammatory reaction/ severe localized reactions in the knee joint and affected knee was drained three days in a row/it might have been 10-20 ml each day; also, device malfunction was identified for the reported lot number.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient initiated treatment with intra-articular synvisc one injection (dose, frequency and indication: unknown) (batch/lot number: 7rsl021, expiry date: 31-may-2020).On an unknown date, after unknown latency, the patient had flare-up/inflammatory reaction.It was reported that the patient had severe localized reactions in the knee joint.On an unknown date, after unknown latency, the patient got the affected knee drained three days in a row, and the volume of aspirate from the knee each day was unknown, it might have been 10-20 ml each day.Action taken: unknown corrective treatment: not reported for all the events.Outcome: unknown for all the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).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 criterion: important medical event (ime) for device malfunction additional information was received on 05-dec-2017 from the non-healthcare professional.The additional event of "affected knee drained three days in a row/it might have been 10-20 ml each day" was added with details.The event verbatim was updated from "flare-up/inflammatory reaction" to "flare-up/inflammatory reaction/ severe localized reactions in the knee joint".The suspect product batch/lot number and expiry date was added.Clinical course updated.Text was amended accordingly.Additional information was received on 22-nov-2017.The serious event of device malfunction with the seriousness criterion of ime was added with details and the case was upgraded to serious.The ptc results were added and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-nov-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and experienced flare-up/inflammatory reaction/ severe localized reactions in the knee joint and had knee effusion.The treatment dates for device and event onset are unknown and therefore a temporal relationship cannot be established.However, 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: 7144034
• MDR Text Key: 96242851
• Report Number: 2246315-2017-00331
• Device Sequence Number: 0
• Product Code: MOZ
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2017
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• 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