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

Lot Number UNKNOWN

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

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Possible infection and he might need to have fluid drained (left knee) [joint infection] hard time bending his knee [joint range of motion decreased] knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more.Arthralgia aggravated; pain upon movement.Swelling: his left knee became swollen.Case narrative: initial information received on 14-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states this case involves a (b)(6) years old male patient for who had possible infection and he might need to have fluid drained (left knee), hard time bending his knee, knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more and swelling/ his left knee became swollen while being treated with 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.On (b)(6) 2021, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) injection at dose of 6 ml, once in left knee (lot - unknown) for osteoarthritis.On the same day, after unknown exact latency, it hurt a little the first couple of days afterwards then patient did some hiking 48 hours post injection and it started to hurt more (arthralgia).The patient went to urgent care and they told him he really needed to have it looked at by his doctor, could be a possible infection and he might need to have fluid drained (arthritis infective).The pain resolved in 2021 until he did some very strenuous climbing/hiking/lifting then he noticed increased pain and swelling of that knee on (b)(6) 2021.On (b)(6) 2021, after latency of 18 days, the knee was slightly sore, then yesterday it was very sore and on (b)(6) 2021, even worse.Patient also said that it was painful to walk especially up stairs and has a hard time bending his knee (pain, joint range of motion decreased; start date: (b)(6) 2021; latency: 18 days).The patient had to leave for vacation that day and he called his doctor office when he got to his destination.Reportedly, the left knee became swollen and the knee hurts when walking.They recommended that he stay off his feet, use ice and otc anti-inflammatory meds and on (b)(6) 2021, it was much worse.Action taken: not applicable for all events.Corrective treatment- he stay off his feet, use ice and otc anti-inflammatory meds for arthralgia, joint swelling, possible infection.At time of reporting, the outcome was not recovered / not resolved for all events.Additional information was received on 14-jul-2021 from the patient.The case was upgraded to serious from non-serious.Event added for possible infection and he might need to have fluid drained (left knee).Event verbatim updated for swelling/ his left knee became swollen, knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more, painful to walk especially up stairs/ the knee hurts when walking.Clinical course was updated.Text amended accordingly.

Event Description

Possible infection and he might need to have fluid drained (left knee) [joint infection] hard time bending his knee [joint range of motion decreased] knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more [arthralgia aggravated] ([pain upon movement]) swelling/ his left knee became swollen [swelling of l knee] case narrative: initial information received on 14-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states this case involves a 64 years old male patient for who had possible infection and he might need to have fluid drained (left knee), hard time bending his knee, knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more and swelling/ his left knee became swollen while being treated with 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.On (b)(6) 2021, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) (strength: 48mg/6ml) injection, liquid (solution) at dose of 6 ml, once in left knee (lot - unknown) for osteoarthritis.On the same day, after unknown exact latency, it hurt a little the first couple of days afterwards then patient did some hiking 48 hours post injection and it started to hurt more (arthralgia).The patient went to urgent care and they told him he really needed to have it looked at by his doctor, could be a possible infection and he might need to have fluid drained (arthritis infective).The pain resolved in 2021 until he did some very strenuous climbing/hiking/lifting then he noticed increased pain and swelling of that knee on (b)(6) 2021.On (b)(6) 2021, after latency of 18 days, the knee was slightly sore, then yesterday it was very sore and on (b)(6) 2021, even worse.Patient also said that it was painful to walk especially up stairs and has a hard time bending his knee (pain, joint range of motion decreased; start date: (b)(6) 2021; latency: 18 days).The patient had to leave for vacation that day and he called his doctor office when he got to his destination.Reportedly, the left knee became swollen and the knee hurts when walking.They recommended that he stay off his feet, use ice and otc anti-inflammatory meds and on (b)(6) 2021, it was much worse.Action taken: not applicable for all events corrective treatment- he stay off his feet, use ice and otc anti-inflammatory meds for arthralgia, joint swelling, possible infection at time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one.Batch number: unknown; global ptc number: 100141541.The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) process.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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 27-jul-2021 with summarized conclusion as no assessment possible additional information was received on 14-jul-2021 from the patient.The case was upgraded to serious from non-serious.Event added for possible infection and he might need to have fluid drained (left knee).Event verbatim updated for swelling/ his left knee became swollen, knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more, painful to walk especially up stairs/ the knee hurts when walking.Clinical course was updated.Text amended accordingly.Follow up information received on 14-jul-2021 from other healthcare professional.Ptc number added.Additional information was received on 27-jul-2021 from other healthcare professional.Global ptc number and its results were added.Clinical course updated.Text amended accordingly.

Event Description

Possible infection and he might need to have fluid drained (left knee) [joint infection] hard time bending his knee [joint range of motion decreased] knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more [arthralgia aggravated] ([pain upon movement]) swelling/ his left knee became swollen [swelling of l knee].Case narrative: initial information received on 14-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from united states.This case involves a 64 years old male patient for who had possible infection and he might need to have fluid drained (left knee), hard time bending his knee, knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more and swelling/ his left knee became swollen while being treated with 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.On (b)(6) 2021, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) (strength: 48mg/6ml) injection, liquid (solution) at dose of 6 ml, once in left knee (lot - unknown) for osteoarthritis.On the same day, after unknown exact latency, it hurt a little the first couple of days afterwards then patient did some hiking 48 hours post injection and it started to hurt more (arthralgia).The patient went to urgent care and they told him he really needed to have it looked at by his doctor, could be a possible infection and he might need to have fluid drained (arthritis infective).The pain resolved in 2021 until he did some very strenuous climbing/hiking/lifting then he noticed increased pain and swelling of that knee on (b)(6)2021.On (b)(6) 2021, after latency of 18 days, the knee was slightly sore, then yesterday it was very sore and on (b)(6) 2021, even worse.Patient also said that it was painful to walk especially up stairs and has a hard time bending his knee (pain, joint range of motion decreased; start date: (b)(6) 2021; latency: 18 days).The patient had to leave for vacation that day and he called his doctor office when he got to his destination.Reportedly, the left knee became swollen and the knee hurts when walking.They recommended that he stay off his feet, use ice and otc anti-inflammatory meds and on (b)(6) 2021, it was much worse.Action taken: not applicable for all events.Corrective treatment- he stay off his feet, use ice and otc anti-inflammatory meds for arthralgia, joint swelling, possible infection.At time of reporting, the outcome was not recovered / not resolved for all events.A product technical complaint (ptc) was initiated on 14-jul-2021 for synvisc one.Batch number: unknown; global ptc number: 100141541.The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) process.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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 27-jul-2021 with summarized conclusion as no assessment possible additional information was received on 14-jul-2021 from the patient.The case was upgraded to serious from non-serious.Event added for possible infection and he might need to have fluid drained (left knee).Event verbatim updated for swelling/ his left knee became swollen, knee was slightly sore; very sore; even worse/ hurt a little the first couple of days afterwards/ did some hiking 48 hours post injection and it started to hurt more, painful to walk especially up stairs/ the knee hurts when walking.Clinical course was updated.Text amended accordingly.Follow up information received on 14-jul-2021 from other healthcare professional.Ptc number added.Additional information was received on 27-jul-2021 from other healthcare professional.Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Based on the information previously received, the code of annexure e has been updated from e2123 to e1906.Local comments: *downgrade*.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 12216572
• MDR Text Key: 263106233
• Report Number: 2246315-2021-00127
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male