MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144); Dizziness (2194); Arthralgia (2355); Joint Swelling (2356); Malaise (2359); No Code Available (3191)

Event Date 09/10/2019

Event Type  Injury  

Event Description

Difficulty in going down the stairs [walking difficulty].Pain in her right knee [aching (r) knee].Joint effusion/swollen where she was punctured, refers worsening [joint effusion].Swelling of her right knee/swollen where she was punctured, refers worsening [swelling of r knee].Blood test was performed, which resulted high cholesterol (225 does not refer units) [cholesterol blood increased].Discomfort in the right knee [discomfort in joints].Vomiting [vomiting].Malaise [malaise].Dizziness [dizziness].Nausea [nausea].Synvisc one given for chondromalacia [device use in unapproved indication].Assuming she had a bad infiltration [unevaluable event].Case narrative: based on additional information received on 10-oct-2019, this case initially assessed as non-serious was updated to serious as intervention was required for events of swelling of her right knee/swollen where she was punctured, refers worsening, joint effusion/swollen where she was punctured, refers worsening, pain in her right knee, difficulty in going down the stairs.This case is linked to case (b)(4) (multiple devices).Initial information received on 23-sep-2019 from (b)(6) regarding an unsolicited valid serious case received from a physician by sales representative.This case involves a (b)(6) female patient who experienced difficulty in going down the stairs, vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units), and discomfort in the right knee (latency: few days for all events) assuming she had a bad infiltration, synvisc one given for chondromalacia (latency: same day), while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had allergy from hyoscine.Patient denied any pathology.Concomitant medications include calcium.Patient denied allergies to hyaluronic acid, referred that she applied every day in facial cream on the face without discomfort.On (b)(6) 2019, patient was fine, she could dance without problems.On (b)(6) 2019 or (b)(6) 2019 (patient does not remember well), few weeks ago, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate), formulation unknown via intra-articular route, at dose of 6 ml once (lot - unknown) in right knee for grade 2 chondromalacia.The information on lot number was requested.The patient was at rest for 3 days without any discomfort after synvisc one application.Patient referred that she complied with all the indications of her treating physician, after synvisc application.The patient assumed she had a bad infiltration (same day after starting use of hylan g-f 20 sodium hyaluronate), the patient decided to perform the second infiltration with other physician.On (b)(6) 2019, few days later, the patient had joint effusion and presented with swelling of her right knee, pain in her right knee, swollen where she was punctured, refers worsening, difficulty in going down the stairs, presents nausea, dizziness, malaise and vomiting (intervention was required for difficulty in going down the stairs, pain in her right knee, joint effusion, swelling of her right knee/swollen where she was punctured, refers worsening and discomfort in the right knee was).The patient was recovered from dizziness, malaise, nausea, and vomiting on the same day.On same day, after few days of synvisc one administration, a blood test was performed, which resulted high cholesterol (225 does not refer units).It was reported that the patient had improvement in the left knee (the knee that did not receive synvisc), but discomfort in the right knee on an unknown date in 2019 (latency: unknown).On (b)(6) 2019, the patient recovered from swelling and right knee pain.On (b)(6) 2019, patient recovered from joint effusion.It was reported that in 1 month the patient will undergo high cholesterol control.Reportedly, the action taken with the medicine was none.Action taken- not applicable for all events.Corrective treatment- atorvastatin for high cholesterol; corticosteroid (no referred name) im, ice, ointment, no referred name and spray (no referred name to deflate) for swelling of her right knee/swollen where she was punctured, refers worsening, joint effusion/swollen where she was punctured, refers worsening, pain in her right knee, difficulty in going down the stairs; not reported for rest all events.The patient outcome is reported as recovered / resolved for joint effusion/swollen where she was punctured, refers worsening, nausea, dizziness, vomiting, malaise, swelling of her right knee/swollen where she was punctured, refers worsening, pain in her right knee; unknown for assuming she had a bad infiltration, difficulty in going down the stairs, blood test was performed, which resulted high cholesterol (225 does not refer units), discomfort in the right knee; not applicable for synvisc one given for chondromalacia.A product technical complaint was initiated and results were pending for the same.Reporter causality: the causality assessment by the reporter was associated for vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units).Additional information was received on 10-oct-2019 from healthcare professional.Event added for difficulty in going down the stairs, vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units), synvisc one for chondromalacia and discomfort in the right knee.Medical history and concomitant medications added.Clinical course was updated, and text amended accordingly.

Event Description

Difficulty in going down the stairs [walking difficulty] inflammation [joint inflammation] ([aching (r) knee], [joint effusion], [swelling of r knee]) blood test was performed, which resulted high cholesterol (225 does not refer units) [cholesterol blood increased] discomfort in the right knee [discomfort in joints] vomiting [vomiting] malaise [malaise] dizziness [dizziness] nausea [nausea] assuming she had a bad infiltration [unevaluable event] patient denied that synovial fluid was removed [device use issue] case narrative: based on additional information received on 10-oct-2019, this case initially assessed as non-serious was updated to serious as intervention was required for events of swelling of her right knee/swollen where she was punctured, refers worsening, joint effusion/swollen where she was punctured, refers worsening, pain in her right knee, difficulty in going down the stairs.This case was linked to case (b)(4) (multiple devices).Initial information received on 23-sep-2019 from peru regarding an unsolicited valid serious case received from a physician by sales representative.This case involves a 58 years old female patient who experienced difficulty in going down the stairs, vomiting, malaise, nausea, dizziness, blood test was performed, which resulted high cholesterol (225 does not refer units), and discomfort in the right knee (latency: few days for all events) assuming she had a bad infiltration, patient denied that synovial fluid was removed (latency: same day), inflammation (latency: unknown) while she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had allergy from hyoscine.Patient denied any pathology.Patient denied allergies to hyaluronic acid, referred that she applied every day in facial cream on the face without discomfort.Concomitant medications include calcium for grade 2 chondromalacia and hyaluronic acid.On (b)(6) 2019, patient was fine, she could dance without problems.On (b)(6) 2019 or (b)(6) 2019 (patient does not remember well), prior to the injection, local cleaning was performed, then local anesthesia was applied, and all precautions were taken during the process.The patient denied pain from the application and referred that the anesthesia hurt the most.After 3-4 minutes following the process, the patient received hylan g-f 20, sodium hyaluronate, formulation unknown via intra-articular route, at dose of 6 ml once (batch/lot number and expiration date - unknown) (the information on lot number was requested) in right knee for osteoarthritis grade 2-3.Patient denied that synovial fluid was removed (latency: same day).It was confirmed by the patients physician that she received the suspect product for her osteoarthritis.The patient assumed she had a bad infiltration (same day after starting use of hylan g-f 20 sodium hyaluronate), the patient decided to perform the second infiltration with other physician.The patient was at rest for 3 days without any discomfort after hylan g-f 20, sodium hyaluronate application.Patient referred that she complied with all the indications of her treating physician, after synvisc application.On an unknown date in (b)(6) 2019, after 48 hours of administration of injection, the patient had joint effusion but denied systemic commitment.On (b)(6) 2019, few days later, the patient presented with swelling of her right knee, pain in her right knee, swollen where she was punctured, refers worsening, difficulty in going down the stairs, presents nausea, dizziness, malaise and vomiting (intervention was required for difficulty in going down the stairs, pain in her right knee, joint effusion, swelling of her right knee/swollen where she was punctured, refers worsening and discomfort in the right knee was).The patient was recovered from dizziness, malaise, nausea, and vomiting on the same day.On same day, after few days of hylan g-f 20, sodium hyaluronate administration, a blood test was performed, which resulted high cholesterol (225 does not refer units).It was reported that the patient had improvement in the left knee (the knee that did not receive synvisc), but discomfort in the right knee on an unknown date in 2019 (latency: unknown).On (b)(6) 2019, the patient recovered from swelling and right knee pain.On(b)(6) 2019, patient recovered from joint effusion.It was reported that in 1 month the patient will undergo high cholesterol control.Reportedly, the action taken with the medicine was none.On an unknown date in 2019, after the injection, patient experienced inflammation (latency: unknown) and received corticosteroids intramuscular route (im) as a corrective treatment.This event was assessed as serious and was leading to intervention.On (b)(6) 2019, lab results of the patient revealed her cholesterol was 192 (units unspecified).It was reported that the patient was still experiencing knee pain and swelling at the application area, was recovering from inflammation and joint effusion and had recovered from high cholesterol.Action taken- not applicable for all events.Corrective treatment: atorvastatin for high cholesterol ; corticosteroid (no referred name) im, ice, ointment, no referred name and spray (no referred name to deflate) for difficulty in going down the stairs; corticosteroid im for inflammation; not reported for rest all events.Outcome: recovering resolving for inflammation, joint effusion/swollen where she was punctured, refers worsening; unknown for assuming she had a bad infiltration, difficulty in going down the stairs and discomfort in the right knee; recovered resolved for nausea, dizziness, malaise, blood test was performed, which resulted high cholesterol (225 does not refer units), vomiting; not applicable for patient denied that synovial fluid was removed; not recovered for rest of the events a product technical complaint was initiated and results were pending for the same.Reporter causality: the causality assessment by the reporter was associated for vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units) additional information was received on 10-oct-2019 from healthcare professional.Event added for difficulty in going down the stairs, vomiting, malaise, nausea, pain in her right knee, dizziness, joint effusion/swollen where she was punctured, refers worsening, swelling of her right knee/swollen where she was punctured, refers worsening, blood test was performed, which resulted high cholesterol (225 does not refer units), synvisc one for chondromalacia and discomfort in the right knee.Medical history and concomitant medications added.Clinical course was updated, and text amended accordingly.Additional information received on 24-oct-2019 from healthcare professional.Suspect product indication updated.Indication for concomitant medication of calcium added.Event outcome updated to not recovered for pain in her right knee and swelling of her right knee/swollen where she was punctured, refers worsening; recovering for joint effusion/swollen where she was punctured, refers worsening and recovered for blood test was performed, which resulted high cholesterol (225 does not refer units).Event of inflammation and patient denied that synovial fluid was removed added.Event of synvisc one given for chondromalacia deleted.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 9225926
• MDR Text Key: 163552218
• Report Number: 2246315-2019-00265
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CALCIUM (CALCIUM),UNKNOWN; CALCIUM (CALCIUM),UNKNOWN; HYALURONIC ACID (HYALURONIC ACID),CREAM; HYALURONIC ACID (HYALURONIC ACID),CREAM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR