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

Lot Number 7RSL021

Device Problems Device Contamination With Biological Material (2908); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

This legal spontaneous case from united states was received on (b)(6) 2018 from the patient's lawyer (other non healthcare professional).This case concerns a (b)(6) female patient who initiated treatment with synvisc one and the same day had pain/ hurts little bit.Also device malfunction was identified for the reported lot number.No previous medications were reported.The patient had no known drug allergies.Patient was a non-smoker.Medical history included arthritis, back pain and thyroid problems.The patient also had hypertension.Concomitant medications included paracetamol (acetaminophen), codeine, azelastine, azithromycin, calcitonin, celecoxib, cefalexin (cephalexin), chlorhexidine gluconate, metronidazole, pantoprazole, alirocumab, (praluent), promethazine hydrochloride (promethazine), levothyroxine sodium (synthroid), amlodipine/telmisartan and tramadol hydrochloride (tramadol).Marital status: married.The patient had history of knee crepitus and edema.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (unknown dose) (batch/ lot number: 7rsl021 and expiry date: may-2020) to her right knee for osteoarthritis of knee/unilateral primary osteoarthritis, right knee.The patient brought the injection in with her.Patient reported no fever, no night sweats, no significant weight gain or weight loss and no exercise intolerance.The patient had a healthy female musculoskeleton.She reported no abnormal mole, no jaundice and no rashes.The patient tolerated the procedure well and was instructed to avoid strenuous activity for 24-48 hours and to use ice, nsaids or paracetamol (tylenol) for pain as needed.The same day, patient had pain and it hurt a little bit.The patient continued to wear the unloader brace.Corrective treatment: brace for pain/ hurts little bit outcome: unknown for both events seriousness criteria: important medical event for device malfunction 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.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018: this case concerns a patient who suffered from right 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.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, pharmacological plausibility of the event to the product cannot be excluded.

Event Description

Upon internal review, on (b)(6) 2018 this case was identified as a duplicate of case (b)(4).Hence, this case was prepared for deletion.This case was cross referenced with case (b)(4).This legal spontaneous case from united states was received on 28-mar-2018 from the patient's lawyer (other non healthcare professional).This case concerns a 71 year old female patient who initiated treatment with synvisc one and the same day had pain/ hurts little bit.Also device malfunction was identified for the reported lot number.No previous medications were reported.The patient had no known drug allergies.Patient was a non-smoker.Medical history included arthritis, back pain and thyroid problems.The patient also had hypertension.Concomitant medications included paracetamol (acetaminophen), codeine, azelastine, azithromycin, calcitonin, celecoxib, cefalexin (cephalexin), chlorhexidine gluconate, metronidazole, pantoprazole, alirocumab, (praluent), promethazine hydrochloride (promethazine), levothyroxine sodium (synthroid), amlodipine/telmisartan and tramadol hydrochloride (tramadol).Marital status: married.The patient had history of knee crepitus and edema.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (unknown dose) (batch/ lot number: 7rsl021 and expiry date: may-2020) to her right knee for osteoarthritis of knee/unilateral primary osteoarthritis, right knee.The patient brought the injection in with her.Patient reported no fever, no night sweats, no significant weight gain or weight loss and no exercise intolerance.The patient had a healthy female musculoskeleton.She reported no abnormal mole, no jaundice and no rashes.The patient tolerated the procedure well and was instructed to avoid strenuous activity for 24-48 hours and to use ice, nsaids or paracetamol (tylenol) for pain as needed.The same day, patient had pain and it hurt a little bit.The patient continued to wear the unloader brace.Corrective treatment: brace for pain/ hurts little bit outcome: unknown for both events seriousness criteria: important medical event for device malfunction 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.Upon internal review on (b)(6) 2018 this case was identified as a duplicate of case (b)(4).All the information pertaining to this case was merged into case (b)(4).Hence, this case was prepared for deletion.Pharmacovigilance comment: sanofi company comment dated 29-mar-2018: this case concerns a patient who suffered from right 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.Additionally, as the concerned lot number has been identified to have malfunction by the company.Therefore, 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
• MDR Report Key: 7446119
• MDR Text Key: 106971767
• Report Number: 2246315-2018-00452
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 03/28/2018

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?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 04/11/2018
• Supplement Dates FDA Received: 05/02/2018
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN(CON.)-START; ACETAMINOPHEN(CON.)-START; ACETAMINOPHEN(CON.)-STOP; ACETAMINOPHEN(CON.)-STOP; AMLODIPINE/TELMISARTAN(CON.)-START; AMLODIPINE/TELMISARTAN(CON.)-START; AMLODIPINE/TELMISARTAN(CON.)-STOP; AMLODIPINE/TELMISARTAN(CON.)-STOP; AZELASTINE(CON.)-START; AZELASTINE(CON.)-START; AZELASTINE(CON.)-STOP; AZELASTINE(CON.)-STOP; AZITHROMYCIN(CON.)-START; AZITHROMYCIN(CON.)-START; AZITHROMYCIN(CON.)-STOP; AZITHROMYCIN(CON.)-STOP; CALCITONIN(CON.)-START; CALCITONIN(CON.)-START; CALCITONIN(CON.)-STOP; CALCITONIN(CON.)-STOP; CELECOXIB(CON.)-START; CELECOXIB(CON.)-START; CELECOXIB(CON.)-STOP; CELECOXIB(CON.)-STOP; CEPHALEXIN(CON.)-START; CEPHALEXIN(CON.)-START; CEPHALEXIN(CON.)STOP; CEPHALEXIN(CON.)STOP; CHLORHEXIDINE GLUCONATE(CON.); CHLORHEXIDINE GLUCONATE(CON.); CODEINE(CON.)-START; CODEINE(CON.)-START; CODEINE(CON.)-STOP; CODEINE(CON.)-STOP; METRONIDAZOLE(CON.)-START; METRONIDAZOLE(CON.)-START; METRONIDAZOLE(CON.)-STOP; METRONIDAZOLE(CON.)-STOP; PANTOPRAZOLE(CON.)-START; PANTOPRAZOLE(CON.)-START; PANTOPRAZOLE(CON.)-START; PANTOPRAZOLE(CON.)-START; PANTOPRAZOLE(CON.)-STOP; PANTOPRAZOLE(CON.)-STOP; PANTOPRAZOLE(CON.)-STOP; PANTOPRAZOLE(CON.)-STOP; PRALUENT(CON.); PRALUENT(CON.); PROMETHAZINE(CON.)-START; PROMETHAZINE(CON.)-START; PROMETHAZINE(CON.)-STOP; PROMETHAZINE(CON.)-STOP; SYNTHROID(CON.)-START; SYNTHROID(CON.)-START; TRAMADOL(CON.)-START; TRAMADOL(CON.)-START; TRAMADOL(CON.)-STOP; TRAMADOL(CON.)-STOP
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 54