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

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on (b)(6) 2017 and (b)(6) 2017 (both information processed together with clock start date of (b)(6) 2017) from other non-health care professional.This case concerns (b)(6) year old female patient who received treatment with synvisc one and later after 6 hours patient had inability to bend her knees or bear weight, had acute onset knee swelling; after few days patient could barely walk, unable to work for 1 week and knee pain/one knee was more "severe" than the other.No medical history, concomitant medication or concurrent condition was provided.Patient had received synvisc-one previously and tolerated it well.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at a dose of 6 ml once (indication and expiry date: unknown) (batch/ lot number: 7rsl021) bilateral injections.On the same day, six hours after injection, patient has spontaneous, acute onset knee swelling, pain, inability to bend her knees or bear weight.On an unknown date in (b)(6) 2017, after unknown latency, it was reported that one knee was more "severe" than the other.Patient had knee pain and could barely walk.Patient returned to hcp (health care professional) on (b)(6) 2017 and would also return for appointment tomorrow.Patient was still using a cane and had been unable to work for 1 week (onset date: (b)(6) 2017; latency: few days) as a result.It was reported that the condition has not completely resolved as of today.Patient was currently being treated with ice packs and pain medications.Corrective treatment: using a cane for could barely walk; ice packs and pain medications for knee pain/one knee was more "severe" than the other; ice packs for acute onset knee swelling; not reported for rest events.Outcome: unknown for unable to work for 1 week and could barely walk; not recovered for rest events.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criterion: significant or permanent disability for could barely walk pharmacovigilance comment: sanofi company comment dated (b)(6) 2017: this case concerns a female patient who has received treatment with synvisc one and could barely walk.The event is temporally related with the device and therefore causal relationship with device cannot be denied.However, lack of information regarding patient's underlying medical condition and relevant medical history makes the complete case assessment difficult.

Event Description

This unsolicited case from united states was received on 07-dec-2017 and 08-dec-2017 (both information processed together with clock start date of 07-dec- 2017) from other non-health care professional this case concerns (b)(6) year old female patient who received treatment with synvisc one and later after 6 hours patient had inability to bend her knees or bear weight, had acute onset knee swelling; after few days patient could barely walk, unable to work for 1 week and knee pain/one knee was more "severe" than the other, also, device malfunction was identified for the reported lot number.No medical history, concomitant medication or concurrent condition was provided.Patient had received synvisc-one previously and tolerated it well.On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at a dose of 6 ml once (indication and expiry date: unknown) (batch/ lot number: 7rsl021) bilateral injections.On the same day, six hours after injection, patient has spontaneous, acute onset knee swelling, pain, inability to bend her knees or bear weight.On an unknown date in (b)(6) -2017, after unknown latency, it was reported that one knee was more "severe" than the other.Patient had knee pain and could barely walk.Patient returned to hcp (health care professional) on (b)(6) 2017 and would also return for appointment tomorrow.Patient was still using a cane and had been unable to work for 1 week (onset date: (b)(6) -2017; latency: few days) as a result.It was reported that the condition has not completely resolved as of today.Patient was currently being treated with ice packs and pain medications.Corrective treatment: using a cane for could barely walk; ice packs and pain medications for knee pain/one knee was more "severe" than the other; ice packs for acute onset knee swelling; not reported for rest events.Outcome: unknown for unable to work for 1 week and could barely walk; not recovered for rest events.Seriousness criteria: important medical event for device malfunction.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 is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.Seriousness criterion: significant or permanent disability for could barely walk additional information was received on 07-dec-2017 and 29-dec-2017 (processed with clock start date of 07-dec- 2017).Global ptc number and ptc results were added.An additional event of device malfunction was added with details.Clinical course was updated and text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 7-dec-2017: this case concerns a female patient who has received treatment with synvisc one from the recalled lot and could barely walk.The event is temporally related with the device and therefore causal relationship with device cannot be denied.Furthermore, the concerned lot number has been identified to have malfunction by the company.However, lack of information regarding patient's underlying medical condition and relevant medical history makes the complete case assessment difficult.

• 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: 7156222
• MDR Text Key: 96111877
• Report Number: 2246315-2017-00283
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• 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): Disability
• Patient Age: 76 YR