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

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

Patient Problems Cramp(s) (2193); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Stiffness in right knee [stiff knees], swelling in right knee [swelling of r knee], pain in right knee [aching (r) knee], cyst at the level of the popliteal fossa (right knee) [popliteal cyst], heavy leg on the right [heaviness in leg], cramps in the calf on the right [cramps calf].Case narrative: this case is linked to case (b)(4) (same patient).Initial information received on 31-oct-2019 regarding an unsolicited valid serious case received from a patient from france.This case involves a (b)(6) years old male patient who after unknown latency experienced stiffness in right knee, swelling in right knee, pain in right knee, cyst at the level of the popliteal fossa (right knee), heavy leg on the right and cramps in the calf on the right, while he used the medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.Patient was treated with hylan g-f 20, sodium hyaluronate (synvisc one) for 10 years in the both knees every 7 to 8 months to allow him to continue his sport.The patient practiced many sport as the extensive cycle: 9 000 in 10 000 km a year and ski.On an unknown date in 2019, (around 7 or 8 months ago before (b)(6) 2019), the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route (infiltration), at a dose of 6 ml once (with an unknown batch number and expiration date) for osteoarthritis in right knee.On an unknown date in 2019, after unknown latency, the patient presented to the infiltration with a cyst at the level of the popliteal fossa which required a draining.On an unknown date in 2019, after unknown latency, during 2 weeks, the patient suffered of swelling, pain, stiffness in the right knee (assessed as serious due to disability marked).The patient used diclofenac sodium (voltarene) locally after the injection.The patient also experienced heavy leg and cramps in the calf on the right during 2 weeks.Patient had to walk with crutches during 2 days.During 2 weeks following the infiltration, patient could not have a practice any more of physical activity.Final diagnosis was cramps in the calf on the right, heavy leg on the right, cyst at the level of the popliteal fossa (right knee), pain in right knee, swelling in right knee and stiffness in right knee.Action taken: not applicable for all events.Corrective treatment: diclofenac sodium (voltarene) and crutches for pain in right knee, swelling in right knee and stiffness in right knee; draining (puncture) for cyst at the level of the popliteal fossa (right knee), not reported for other event outcome: unknown for all events.A product technical complaint was initiated for synvisc one (lot: unknown) on 05-nov-2019 with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi will continue to monitor adverse events to determine if a capa was required.Final investigation completion was 05-nov-2019.Additional information was received on 05-nov-2019 from other healthcare professional.Ptc results were received and text amended accordingly.

Event Description

Stiffness in right knee [stiff knees].Swelling in right knee [swelling of r knee].Pain in right knee [aching (r) knee].Cyst at the level of the popliteal fossa (right knee) [popliteal cyst].Heavy leg on the right [heaviness in leg].Cramps in the calf on the right [cramps calf].Case narrative: this case is linked to case (b)(4) (same patient).Initial information received on 31-oct-2019 regarding an unsolicited valid serious case received from a patient from france.This case involves a 68 years old male patient who after unknown latency experienced stiffness in right knee, swelling in right knee, pain in right knee, cyst at the level of the popliteal fossa (right knee), heavy leg on the right and cramps in the calf on the right, while he used the medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.Patient was treated with hylan g-f 20, sodium hyaluronate (synvisc one) for 10 years in the both knees every 7 to 8 months to allow him to continue his sport.The patient practiced many sport as the extensive cycle: 9 000 in 10 000 km a year and ski.On an unknown date in 2019, (around 7 or 8 months ago before (b)(6) 2019), the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route (infiltration), at a dose of 6 ml once (with an unknown batch number and expiration date) for osteoarthritis in right knee.Information on batch number was requested.On an unknown date in 2019, after unknown latency, the patient presented to the infiltration with a cyst at the level of the popliteal fossa which required a draining.On an unknown date in 2019, after unknown latency, during 2 weeks, the patient suffered of swelling, pain, stiffness in the right knee (assessed as serious due to disability marked).The patient used diclofenac sodium (voltarene) locally after the injection.The patient also experienced heavy leg and cramps in the calf on the right during 2 weeks.Patient had to walk with crutches during 2 days.During 2 weeks following the infiltration, patient could not have a practice any more of physical activity.Final diagnosis was cramps in the calf on the right, heavy leg on the right, cyst at the level of the popliteal fossa (right knee), pain in right knee, swelling in right knee and stiffness in right knee.Action taken: not applicable for all events.Corrective treatment: diclofenac sodium (voltarene) and crutches for pain in right knee, swelling in right knee and stiffness in right knee; draining (puncture) for cyst at the level of the popliteal fossa (right knee), not reported for other event outcome: unknown for all events.A product technical complaint was initiated for synvisc one (lot: unknown) on (b)(6)2019 with global ptc numberv (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi will continue to monitor adverse events to determine if a capa was required.Final investigation completion was (b)(6) 2019.Additional information was received on 05-nov-2019 from other healthcare professional.Ptc results were received and text amended accordingly.Based on information previously received on 05-nov-2019, the aosi comments received from device officer have been added and eu/ca form have been updated.

Event Description

Cyst at the level of the popliteal fossa (right knee) [popliteal cyst].Heavy leg on the right [heaviness in leg].Cramps in the calf on the right [cramps calf].Stiffness in right knee [stiff knees].Swelling in right knee [swelling of r knee].Pain in right knee [aching (r) knee].Case narrative: this case was linked to case (b)(4) (same patient).Initial information received on 31-oct-2019 regarding an unsolicited valid serious case received from a patient from france.This case involves a 68 years old male patient who after unknown latency experienced stiffness in right knee, swelling in right knee, pain in right knee, cyst at the level of the popliteal fossa (right knee), heavy leg on the right and cramps in the calf on the right, while he used the medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.Patient was treated with hylan g-f 20, sodium hyaluronate (synvisc one) for 10 years in the both knees every 7 to 8 months to allow him to continue his sport.The patient practiced many sports as intensive cycling (9000 to 10,000 km a year) and skiing.On an unknown date in 2019, (around 7 or 8 months before (b)(6) 2019), the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route (infiltration), at a dose of 6 ml once (with an unknown batch number and expiration date) for osteoarthritis in right knee.Information on batch number was requested.On an unknown date in 2019, after unknown latency, in the infiltration site, the patient presented with a cyst at the level of the popliteal fossa (assessed as serious due to disability) which required a draining.On an unknown date in 2019, after an unknown latency, for 2 weeks, the patient suffered of swelling, pain, stiffness in the right knee (assessed as serious due to disability).The patient used diclofenac sodium (voltarene) locally after the injection.The patient also experienced heaviness of right leg and cramps in the right calf for 2 weeks which were also assessed as serious due to disability.The patient had to walk with crutches for 2 days.For 2 weeks following the infiltration, the patient could not practice physical activities.Patient mentioned that he had his situation reviews with his rheumatologist, who indicated that the synvisc one product was not the cause of my concerns and that it certainly did not prevent or delay an operation on my knee.Action taken: not applicable for all events.Corrective treatment: diclofenac sodium (voltarene) for pain, swelling and stiffness in right knee; draining (puncture) for cyst at the level of the popliteal fossa (right knee), crutches for all the events.Outcome: unknown for all events.A product technical complaint was initiated for synvisc one (lot: unknown) on 05-nov-2019 with global ptc number 60900.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi will continue to monitor adverse events to determine if a capa was required.Final investigation completion was 05-nov-2019.Additional information was received on 05-nov-2019.Ptc results were received and text amended accordingly.Based on information previously received on 05-nov-2019, the aosi comments received from device officer have been added and eu/ca form have been updated.Additional information received on 14-jan-2020 from patient.Details added.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: 9322461
• MDR Text Key: 185106912
• Report Number: 2246315-2019-00301
• 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,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability