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 Swelling (2091); Tingling (2171); Numbness (2415); Ambulation Difficulties (2544)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 21-dec-2017 from patient.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and after unknown latency lower leg swelled up, had pain in foot, foot swelling/ sole of the foot was swollen, periodic tingling around his foot, could not feel foot on the floor/ numb sensation in foot, very tight and numb sensation in his foot that feels like a high ankle sprain, after 1 day left knee swelled up and knee really hurting at the point of entry of the injection.Also device malfunction was identified for the reported lot number.No past drug, concomitant medication and concurrent condition was provided.Patient had a complicated surgery on his left ankle in (b)(6) 2017 for a very bad achilles tear.Patient also had an arthritic knee.Patient denied any chronic medical conditions.Patient was post knee replacement surgery in his right knee.Prior to the right knee replacement about 2 years ago, he received synvisc in that knee one or two times.Patient also received a couple cortisone shots in the right knee shortly before it was replaced.Patient had no allergies.Doctor used 10% cortisone along with synvisc.On (b)(6) 2017, patient received treatment with intra- articular synvisc one injection (recall lot), at a dose of 6 ml, once (batch/lot number: 7rsl021 and expiration date: not provided) in left knee for left knee osteoarthritis.Patient got a reaction from the injection.Doctor used 10% cortisone along with synvisc, and he might have also received that on the same day, but he was not sure.On (b)(6) 2017, patient's knee swelled up and was really hurting at the point of entry of the injection.Patient denied any strenuous activity between the injection and the onset of symptoms.The pain and swelling in his knee had resolved, but he was now having additional pain in his foot.Patient currently had arthritic pain in his knee than prior to the injection.It was reported that walking was an effort.Patient used a cane prior to the injection and continued to use the cane now.Patient still had to walk carefully.On (b)(6) 2017, patient complained of knee, leg, and foot swelling and periodic tingling around his foot (latency: unknown).The sole of the foot was swollen and he could not feel it on the floor on an unknown date in (b)(6) 2017.Physician told him that it was a big dose of synvisc for him and that next time she might do the 2 ml product with the series.Patient was currently having a very tight and numb sensation in his foot that feels like a high ankle sprain on an unknown date in (b)(6) 2017.He hope that this foot sensation was due to having received recalled product and also hope of it getting better.Patient did not had any blood work done related to his experience.Patient never received any injections in his left knee, other than the synvisc-one received on (b)(6) 2017.Corrective treatment: not reported for all events except device malfunction outcome: recovered for knee really hurting at the point of entry of the injection, left knee swelled up and not recovered for other 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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criteria: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 27-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced swelling of legs, pain in foot, swelling of feet, tingling of extremity, numbness in feet, ankle sprain and joint tightness.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration.Furthermore, 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: 7178760
• MDR Text Key: 97911163
• Report Number: 2246315-2017-00574
• Device Sequence Number: 0
• Product Code: MOZ
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/21/2017

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?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/10/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR