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 Pain (1994); Swelling (2091); Sleep Dysfunction (2517)

Event Date 11/02/2017

Event Type  malfunction  

Event Description

Based on information received on 13-feb-2018, the report previously considered as non-valid became valid (adverse events of unable to sleep, knee very swollen and knee very painful were added).Additionally, the information was received from healthcare professional, so the case became medically confirmed.Based on additional information received on 08-dec- 2017, this case initially considered as non-serious was upgraded to serious (important medical event of device malfunction).This case was cross referenced with case: (b)(4) (cluster).This unsolicited non-valid case from united states was received on 08-dec-2017 from a non-healthcare professional.This case concerns a (b)(6) year old patient of unknown gender who received treatment with synvisc one and later on the same day went to the er (unevaluable event), unable to sleep, knee very swollen and knee very painful; also, device malfunction was identified for the reported lot number.No past drug, or concurrent condition was provided.Medical history included increased cholesterol, reflux/ gastroesophageal reflux disease (gerd).Patient was allergic to iodinated contrast.Concomitant medications included alendronate sodium (alendronate), acetylsalicylic acid (ecotrin), atorvastatin, omeprazole.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose and indication: unknown) (batch/lot number: 7rsl021; expiry date: unknown).The same day, the patient went to the emergency room due to unknown cause (unevaluable event).On (b)(6) 2018, the patient received the injection.The same day, patient's knee was very swollen, painful and was unable to sleep (latency: 19 days).No medical or laboratory test was done for the events.Corrective treatment: not reported for all outcome: recovered for unable to sleep, knee very swollen and knee very painful; unknown for rest a pharmaceutical technical complaint (ptc) was initiated and 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 was completed, corrective and preventive actions would be implemented.Reporter causality: related seriousness criterion: important medical event of device malfunction additional information was received on 08-dec-2017 and 08-jan-2018 (processed together with clock start date 08-dec-2017).Global ptc number and ptc results were added.Additional event of device malfunction was added with details.Clinical course updated and text was amended accordingly.Additional information was received on 13-feb-2018 from clinical coordinator (healthcare professional) and case became medically confirmed.Case report was updated from non-valid to valid case.Age of the patient was added.Medical history and concomitant medications were added.Information regarding suspect drug was added.Additional events of unable to sleep, knee very swollen and knee very painful were added with details.Clinical course updated and text was amended accordingly.Pharmacovigilance comment: sanofi company follow up comment dated 13-feb-2018: this case concerns a patient who went to er, was unable to sleep, had knee swelling, and knee pain after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between the events and the suspect product based on the available information.However, as the concerned lot number has been identified to have malfunction by the company.Therefore, the pharmacological plausibility of the event to the product 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: 7295575
• MDR Text Key: 101484612
• Report Number: 2246315-2018-00339
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• 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): Other
• Patient Age: 81 YR