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 Unspecified Infection (1930); Pain (1994); Swelling (2091); Neck Stiffness (2434); Ambulation Difficulties (2544)

Event Date 11/10/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 19-jan-2018 from the patient.This case concerns a (b)(6) female patient who received treatment with synvisc one and the same day patient couldn't walk, couldn't put any weight in her knee, knee felt stiff, in lot of pain; after unknown latency both knees swelled up, knee drained twice; also, device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.Patient stated in the past (since 2012/2013) patient received a 3 shot series of what she thought might be synvisc.Later, the patient received synvisc from one every 6 months to a year (5 times till now).Patient had a medical history of a knee scope (in 2013) and a torn meniscus.On (b)(6) 2017 (at noon), the patient initiated treatment with single intra-articular synvisc one injection, one injection in each knee, once (batch/lot number: 7rsl021; expiry date: not reported) bilaterally for knee osteoarthritis.The same day, by 4:30 pm the knee felt stiff and by 7:30 pm patient couldn't walk and was in a lot of pain and couldn't put any weight in the knee (latency: 0 day).Patient stated that she was crying that night from the pain.Patient stated the injection was in both knees and both knees swelled up but the right knee was worse (latency: 0 day).Patient said that she has had to get the knee drained twice at her doctor's office on (b)(6) 2017 and (b)(6) 2017 (latency: unknown).Patient confirmed no hospitalizations due to the events.Patient stated that she iced the knee and took unspecified pain pills the first weekend after the injection and missed 3 days of work the following week.Patient stated that the symptoms have resolved, but she still had pain in the knees that she usually had relief from after she took synvisc one, but this time she did not had any relief.At the time of the injection she received a topical and an injectable numbing agent in the knee.Patient stated that she never had a reaction to synvisc one like she had this time.Corrective treatment: ice for knee felt stiff and both knees swelled up; ice and pain pills for in lot of pain; not reported for rest.Outcome: recovered for couldn't walk, couldn't put any weight in her knee, knee felt stiff, both knees swelled up, knee drained twice; not recovered for in lot of pain.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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: important medical event for device malfunction.Pharmacovigilance comment: sanofi company comment dated 25-jan-2018: this case concerns a patient who received treatment with synvisc one from recall lot and later experienced weight bearing difficulty, stiff knees, knee pain, swelling of knees, knee effusion and was unable to walk.A temporal relationship can be established with the product administration.Furthermore, the concerned lot has been identified to have malfunction by the company and causal relationship of the events to the products cannot be excluded.

Event Description

This unsolicited case from united states was received on 19-jan-2018 from the patient.This case concerns a 53 year old female patient who received treatment with synvisc one and after a few hours r.Knee was worse, knee felt stiff/knees were stiff; on the same day patient couldn't walk, had fever, couldn't put any weight in her knee, both knees swelled up/ knees were swollen, in lot of pain; after unknown latency, knee drained twice; also, device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.Patient stated in the past (since 2012/2013) patient received a 3 shot series of what she thought might be synvisc.Later, the patient received synvisc from one every 6 months to a year (5 times till now).Patient had a medical history of a knee scope (in 2013) and a torn meniscus.On (b)(6) 2017 (at 11:30 hours), the patient initiated treatment with single intra-articular synvisc one injection, one injection in each knee, once (batch/lot number: 7rsl021; expiry date: not reported) bilaterally for knee osteoarthritis.The same day, by 4:30 pm the knee felt stiff, by 5:30 could not bear weight on legs and by 7:30 pm patient couldn't walk and was in a lot of pain and couldn't put any weight in the knee (latency: 0 day).Patient used walker to get around from sofa to toilet to bed.Patient stated that she was crying that night from the pain.Patient took pain pills for 4 days.Patient ran a fever for 3 days.Patient stated the injection was in both knees and both knees swelled up but the right knee was worse (latency: 0 day).Patient said that she has had to get the knee drained twice at her doctor's office on (b)(6) 2017 (latency: unknown).Patient confirmed no hospitalizations due to the events.Patient stated that she iced the knee and took unspecified pain pills the first weekend after the injection and missed 3 days of work the following week.Patient stated that the symptoms have resolved, but she still had pain in the knees that she usually had relief from after she took synvisc one, but this time she did not had any relief.At the time of the injection she received a topical and an injectable numbing agent in the knee.Patient stated that she never had a reaction to synvisc one like she had this time.Corrective treatment: steroid injection for couldn't put any weight in her knee/could not bear any weight on legs, r.Knee was worse, couldn't walk/used as walker to get from sofa to toilet to bed, in lot of pain, painful to walk, knee felt stiff/knees were stiff, both knees swelled up/ knees were swollen and knee drained twice/had fluid drained out; not reported for fever outcome: not recovered for painful to walk, in lot of pain and device malfunction; unknown for r.Knee was worse; recovered for other events except did not have relief/did not work/ still have knee pain 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 is completed, corrective and preventive actions would be implemented.Seriousness criterion: required intervention for all the events except fever and device ineffective additional information was received on 01-mar-2018 from the patient.Events of r.Knee was worse and fever were added.Event of couldn't put any weight in her knee was updated to couldn't put any weight in her knee/could not bear any weight on legs; couldn't walk was updated to couldn't walk/used as walker to get from sofa to toilet to bed; knee felt stiff was updated to knee felt stiff/knees were stiff; both knees swelled up was updated to both knees swelled up/ knees were swollen.Expiry date was added.Pharmacovigilance comment: sanofi company follow up comment dated (b)(6) 2018: this case concerns a patient who received treatment with synvisc one injection from the recalled lot and later experienced weight bearing difficulty, condition worsened, knee pain, stiff knees, swelling of knees, knee effusion and being unable to walk.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: 7246770
• MDR Text Key: 99915835
• Report Number: 2246315-2018-00236
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2018
• Patient Sequence Number: 1
• Treatment: SYNVISC ONE(PREV.); SYNVISC(PREV.) - START; SYNVISC(PREV.) - START; SYNVISC(PREV.) - STOP UNKNOWN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 53 YR