MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC; INTRA-ARTICULAR INJECTION

Lot Number 6RSA002A

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Edema (1820); Pain (1994); Swelling (2091); Weakness (2145); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Type  malfunction  

Event Description

Clinical condition chondromalacia patellae/cartilaginous clefts worsened [chondromalacia] ([condition worsened]).Knee snapped [joint crepitation].Cyst that was developed in one the knees [synovial cyst].Soft lateral bascule of patella discreetly high [floating patella].Could not climb stairs [muscle weakness lower limb].Quantity of liquid in the popliteal tendon sheath with cyst formation 1.3 cm [tendon disorder].Knee was cramping/feels pain/pain [knee pain].Joint effusion [joint effusion].Intensive edema of fat lateral infra-patellar, indicating hyper-pressure of extensor mechanism.[edema knees].Synvisc/synvisc one for chondromalacia patellae/cartilaginous clefts [off label use].Case narrative: this unsolicited case from united states was received on 03-apr-2018 from a patient.This case involves a (b)(6) female patient who received treatment with synvisc and synvisc one for chondromalacia patellae/cartilaginous clefts (off label use) and later after unknown latency had clinical condition chondromalacia patellae/cartilaginous clefts worsened, could not climb stairs because her knee snapped, cyst that was developed in one the knees, could not climb stairs, intensive edema of fat lateral infra-patellar, indicating hyper-pressure of extensor mechanism, soft lateral bascule of patella discreetly high, quantity of liquid in the popliteal tendon sheath with cyst formation 1.3 cm, knee was cramping/feels pain/pain, joint effusion.No past drug, medical history or concurrent condition was provided.The concomitant medications were denied.On an unknown date, the initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch number: 7rsl009zc; expiry date: 31-mar-2020) for chondromalacia patellae/cartilaginous clefts (off label use).On (b)(6) 2018, the patient received treatment with intra-articular synvisc injection at a dose of 2 ml every week (batch/lot number: 6rsa002a, expiry date: nov-2019) for chondromalacia patellae/cartilaginous clefts (off label use).The patient used synvisc in 1 knee (3 applications) and synvisc one in other knee (1 application).On an unknown date, after unknown latency, the patient's clinical condition chondromalacia patellae/cartilaginous clefts worsened and the patient alleged that she could not climb stairs because her knee snapped and she experienced pain, besides a cyst that was developed in one of the knees.As a corrective treatment, the patient made physiotherapy.On (b)(6) 2018, the patient performed an ultrasound exam and the result was "nothing".On an unknown date in (b)(6) 2018, as an action taken, the patient discontinued the treatment with synvisc.On (b)(6) 2018, the patient performed a resonance examination, and the result was "intensive edema of fat lateral infra-patellar, indicating hyper-pressure of extensor mechanism.The edema and the obliteration of prior fat pre-femoral were associated.On an unknown date, after unknown latency, the patient had soft lateral bascule of patella discreetly high and joint effusion with quantity of liquid in the popliteal tendon sheath with cyst formation 1,3 cm.The others were integrated and preserved." according to the patient, there was other possible explanation for the event.It was not reported the patient's physician was not aware of this case.No further data was provided.The patient informed that her report was not about of the lack of efficacy but of worsening grave of her condition.Action taken: permanently discontinued for synvisc.Corrective treatment: physiotherapy for could not climb stairs, clinical condition chondromalacia patellae/cartilaginous clefts worsened, could not climb stairs because her knee snapped, cyst that was developed in one the knees; not reported for rest of the events.Outcome: recovering for could not climb stairs because her knee snapped, clinical condition chondromalacia patellae/cartilaginous clefts worsened, cyst that was developed in one the knees, knee was cramping/feels pain/pain; unknown for could not climb stairs, intensive edema of fat lateral infra-patellar, indicating hyper-pressure of extensor mechanism, soft lateral bascule of patella discreetly high, quantity of liquid in the popliteal tendon sheath with cyst formation 1.3 cm, joint effusion.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).The production and quality control documentation for lot 6rsa002a expiration date nov-2019 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review and lot frequency analysis for lot 6rsa002a no capa is required.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).The production and quality control documentation for lot 7rsl009zc expiration date mar-2020 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review and lot frequency analysis for lot 7rsl009zc no capa is required.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information was received on 16-apr-2018.Global ptc number and ptc (pharmaceutical technical complaint) results were added.Text was amended accordingly.Additional information was received on 13-apr-2018.Therapy details (batch number and expiry date) of suspect products were added.Clinical course was updated and text was amended accordingly.Additional information was received on 02-may-2018.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 18-may-2018.Global ptc number and ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7854679
• MDR Text Key: 120109257
• Report Number: 2246315-2018-00564
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2019
• Device Lot Number: 6RSA002A
• Was Device Available for Evaluation?: No
• 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 Age: 37 YR
• Patient Weight: 50