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

Lot Number BRSL039C

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 04/29/2022

Event Type  Injury  

Event Description

Septic knee/infection got worse and ended up in the hospital for two months [septic arthritis] ([knee swelling], [pain in knee], [condition aggravated], [injection site joint effusion], [arthrocentesis]).Had difficulty walking [walking difficulty].Case narrative: initial information received on 03-aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient) from canada.This case involves a 77 years old male patient who had septic knee/infection got worse and ended up in the hospital for two months and had difficulty walking with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical treatment included cortisone.The patient's past medical history, vaccination(s) and family history were not provided.In (b)(6) 2022, the patient received synvisc one injection 6 ml intra-articular (with unknown batch number, strength, frequency, expiry date) for osteoarthritis.Information on batch number was requested on (b)(6) 2022 the patient mentioned on the synvisc patient support line that he had a synvisc-one injection in the right knee on (b)(6) 2022 for osteoarthritis.The patient said he was fine until about midnight then his knee swelled up (joint swelling) (latency: same day), he was in pain (arthralgia) (latency: same day), had difficulty walking (gait disturbance) and he ended up with a septic knee (arthritis bacterial; medically significant) (latency unknown).The next day he returned to the clinic where he was provided pain killers and anti-inflammatories.The following day his knee was worse (condition aggravated) (latency unknown), he then again returned and had fluids removed from his (knee injection site joint effusion), (arthrocentesis).The patient went to the hospital on the 30th some testing was done, was sent home for three days, infection got worse and ended up in the hospital for two months.Patient has had 4 surgeries since the injection.He now has half a knee waiting for the infection to clear up and to have a complete knee surgery.Patient also took antibiotics intravenously twice a day and had a knee cleansing to remove as much of the infection as possible.Patient said he was receiving cortisone injections previously.Corrective treatment: pain killers, anti-inflammatories, antibiotics and surgery.Action taken: not applicable for the events.Outcome: not recovered for the events.Seriousness criteria: medically significant.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

(b)(6) comment dated (b)(6) 2022: this case involves a patient had septic knee/infection got worse and ended up in the hospital for two months, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.

Event Description

Septic knee/infection got worse and ended up in the hospital for two months [septic arthritis] ([injection site joint swelling], [injection site joint pain], [condition aggravated], [injection site joint effusion], [arthrocentesis]) had difficulty walking [walking difficulty] case narrative: initial information received on 03-aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient) from canada.This case involves a 77 years old male patient who had septic knee/infection got worse and ended up in the hospital for two months and had difficulty walking with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical treatment included cortisone.The patient's past vaccination(s) and family history were not provided.The patient had no medical history, concomitant disease, or risk factor.On (b)(6) 2022 at 10:40 am, the patient received synvisc one injection (48 mg/6ml) at dose of 6 ml via intra-articular route in right knee (with unknown frequency, expiry date) for osteoarthritis (batch number: brsl039c) the patient said he was fine until about midnight then on (b)(6) 2022 at 3.00 am in the morning, patient went to his bathroom and his knee was very painful/he was in pain (injection site joint pain) (latency: 1 day), his knee swelled up (injection site joint swelling) (latency: 1 day), had difficulty walking (gait disturbance).The next day he returned to the clinic where he was provided pain killers and anti-inflammatories.On saturday, (b)(6) 2022, the following day his knee was worse (condition aggravated) (latency: 2 days), patient went to the hospital and had fluids removed from his knee (injection site joint effusion), (arthrocentesis).Then, some testing was done and was sent home for three days.On sunday morning (b)(6) 2022), he received a phone call from the hospital as he had an infection and patient mentioned he ended up with a septic knee (arthritis bacterial; medically significant, required hospitalization and surgical intervention) (latency: 2 days).On same day (b)(6) 2022), the patient was hospitalised for 3/4 days and was sent back home.Further, the infection got worse, so he went back to the hospital from (b)(6) 2022.As corrective treatment on (b)(6) 2022, he had a partial knee replacement.He ended up in the hospital for two months until (b)(6) 2022.Patient has had 4 surgeries since the injection.He now had half a knee waiting for the infection to clear up and to have a complete knee surgery.Patient also took antibiotics intravenously twice a day and had a knee cleansing to remove as much of the infection as possible.Patient said he was receiving cortisone injections previously.He would see his surgeon on (b)(6) 2022 and would see if he can have a full knee replacement.As of 16-aug-2022, the patient was infection free, no pain anymore.It was unknown if the patient experienced any additional symptoms/events.Action taken: not applicable for both the events.Corrective treatment: pain killers, anti-inflammatories, antibiotics, 4 surgeries since the injection, partial knee replacement for arthritis bacterial, not reported for difficulty walking outcome: recovered in aug-2022 for arthritis bacterial, not recovered for difficulty walking product technical complaint (ptc) was initiated with global ptc number 100249991 on 04-aug-2022 for synvisc one.Batch number: unknown sample status was not available and ptc was set in process additional information was received on 16-aug-2022 and 18-aug-2022 (processed together as significant) from a patient.Outcome, start date, hospitalization dates, latency, corrective treatment was updated for event arthritis bacterial and its associated symptoms.Injection date was updated.Batch number was added.Clinical course was updated.Text was amended accordingly.

Manufacturer Narrative

Sanofi company comment for follow up dated 16-aug-2022: follow up information received does not change prior case assessment.This case involves a patient had septic knee/infection got worse and ended up in the hospital for two months, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.

Event Description

Septic knee/infection got worse and ended up in the hospital for two months [septic arthritis] ([injection site joint swelling], [injection site joint pain], [condition aggravated], [injection site joint effusion], [arthrocentesis]) had difficulty walking [walking difficulty].Case narrative: initial information received on 03-aug-2022 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case involves a 77 years old male patient who had septic knee/infection got worse and ended up in the hospital for two months and had difficulty walking with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical treatment included cortisone.The patient's past vaccination(s) and family history were not provided.The patient had no medical history, concomitant disease, or risk factor.On (b)(6) 2022 at 10:40 am, the patient received synvisc one injection, liquid (solution) (48 mg/6ml) at dose of 6 ml once via intra-articular route in right knee for osteoarthritis (batch number: brsl039c, expiry date: 30-sep-2024).The patient said he was fine until about midnight then on (b)(6) 2022 at 3.00 am in the morning, patient went to his bathroom and his knee was very painful/he was in pain (injection site joint pain) (latency: 1 day), his knee swelled up (injection site joint swelling) (latency: 1 day), had difficulty walking (gait disturbance).The next day he returned to the clinic where he was provided pain killers and anti-inflammatories.On saturday, (b)(6) 2022, the following day his knee was worse (condition aggravated) (latency: 2 days), patient went to the hospital and had fluids removed from his knee (injection site joint effusion), (arthrocentesis).Then, some testing was done and was sent home for three days.On sunday morning (b)(6) 2022, he received a phone call from the hospital as he had an infection and patient mentioned he ended up with a septic knee (arthritis bacterial; medically significant, required hospitalization and surgical intervention) (latency: 2 days).On same day (b)(6) 2022, the patient was hospitalised for 3/4 days and was sent back home.Further, the infection got worse, so he went back to the hospital from mid-(b)(6)-2022.As corrective treatment on (b)(6) 2022, he had a partial knee replacement.He ended up in the hospital for two months until (b)(6) 2022.Patient has had 4 surgeries since the injection.He now had half a knee waiting for the infection to clear up and to have a complete knee surgery.Patient also took antibiotics intravenously twice a day and had a knee cleansing to remove as much of the infection as possible.Patient said he was receiving cortisone injections previously.He would see his surgeon on (b)(6) 2022 and would see if he can have a full knee replacement.As of (b)(6) 2022, the patient was infection free, no pain anymore.It was unknown if the patient experienced any additional symptoms/events.Action taken: not applicable for all the events.Corrective treatment: pain killers, anti-inflammatories, antibiotics, 4 surgeries since the injection, partial knee replacement for arthritis bacterial, not reported for difficulty walking.Outcome: recovered in (b)(6) 2022 for arthritis bacterial, not recovered for difficulty walking.A ptc (product technical complaint) was initiated on 04-aug-2022 for synvisc one (with batch number: brsl039c and expiration date: 30-sep-2024) with global ptc number: (b)(4).The same status was not received and the ptc stated: the production and quality control documentation for lot number brsl039c expiration date (2024-09) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number brsl039c no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored 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.As of 19-sep-2022 there were 12 complaints on file for lot# brsl039 and all related sublots.1 complaint was on file for lot number brsl039: (1) adverse event report.There are 10 complaints on file for lot# brsl039c: (9) adverse event reports and (1) extrusion issue.Sanofi will continue to monitor complaints as stated to determine if a capa was required.1 complaint is on file for lot# brsl039d: (1) syringe tip broken.The final investigation was completed on 26-sep-2022 with summarized conclusion as no assessment possible.Reporter causality: not reported for all the events.Company causality: reportable for all the events.Additional information was received on 16-aug-2022 and 18-aug-2022 (processed together as significant) from a patient.Outcome, start date, hospitalization dates, latency, corrective treatment was updated for event arthritis bacterial and its associated symptoms.Injection date was updated.Batch number was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 18-aug-2022.Batch number was added.Text amended accordingly.Additional information was received on 02-sep-2022: no significant information was received.Additional information was received on 20-sep-2022.Global ptc number and ptc results added.Text amended accordingly.Additional information was received on 26-sep-2022 from the quality department.Expiration date was added.Ptc result date and details was updated.Text amended accordingly.

Event Description

Septic knee/infection got worse and ended up in the hospital for two months [arthritis infective nos] ([injection site joint swelling], [injection site joint pain], [condition aggravated], [injection site joint effusion], [arthrocentesis]) had difficulty walking [walking difficulty].Case narrative: initial information received on 03-aug-2022 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case involves a 77 years old male patient who had septic knee/infection got worse and ended up in the hospital for two months and had difficulty walking with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical treatment included cortisone.The patient's past vaccination(s) and family history were not provided.The patient had no medical history, concomitant disease, or risk factor.On (b)(6) 2022 at 10:40 am, the patient received synvisc one injection, liquid (solution) (48 mg/6ml) at dose of 6 ml once via intra-articular route in right knee for osteoarthritis (batch number: brsl039c, expiry date: 30-sep-2024).The patient said he was fine until about midnight then on (b)(6) 2022 at 3.00 am in the morning, patient went to his bathroom and his knee was very painful/he was in pain (injection site joint pain) (latency: 1 day), his knee swelled up (injection site joint swelling) (latency: 1 day), had difficulty walking (gait disturbance).The next day he returned to the clinic where he was provided pain killers and anti-inflammatories.On saturday, (b)(6) 2022, the following day his knee was worse (condition aggravated) (latency: 2 days), patient went to the hospital and had fluids removed from his knee (injection site joint effusion), (arthrocentesis).Then, some testing was done and was sent home for three days.On sunday morning ( (b)(6) 2022), he received a phone call from the hospital as he had an infection and patient mentioned he ended up with a septic knee (arthritis infective; medically significant, required hospitalization and surgical intervention) (latency: 2 days).On same day ( (b)(6) 2022), the patient was hospitalised for 3/4 days and was sent back home.Further, the infection got worse, so he went back to the hospital from (b)(6) 2022.As corrective treatment on (b)(6) 2022, he had a partial knee replacement.He ended up in the hospital for two months until (b)(6) 2022.Patient has had 4 surgeries since the injection.He now had half a knee waiting for the infection to clear up and to have a complete knee surgery.Patient also took antibiotics intravenously twice a day and had a knee cleansing to remove as much of the infection as possible.Patient said he was receiving cortisone injections previously.He would see his surgeon on (b)(6) 2022 and would see if he can have a full knee replacement.As of (b)(6) 2022, the patient was infection free, no pain anymore.It was unknown if the patient experienced any additional symptoms/events action taken: not applicable for all the events corrective treatment: pain killers, anti-inflammatories, antibiotics, 4 surgeries since the injection, partial knee replacement for arthritis bacterial, not reported for difficulty walking outcome: recovered in (b)(6) 2022 for arthritis bacterial, not recovered for difficulty walking.A ptc (product technical complaint) was initiated on 04-aug-2022 for synvisc one (with batch number: brsl039c and expiration date: 30-sep-2024) with global ptc number: 100249991.The same status was not received and the ptc stated: the production and quality control documentation for lot number brsl039c expiration date (2024-09) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number brsl039c no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored 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.As of 19-sep-2022 there were 12 complaints on file for lot# brsl039 and all related sublots.1 complaint was on file for lot number brsl039: (1) adverse event report.There are 10 complaints on file for lot# brsl039c: (9) adverse event reports and (1) extrusion issue.Sanofi will continue to monitor complaints as stated to determine if a capa was required.1 complaint is on file for lot# brsl039d: (1) syringe tip broken.The final investigation was completed on 26-sep-2022 with summarized conclusion as no assessment possible.Reporter causality: not reported for all the events.Company causality: reportable for all the events.Additional information was received on 16-aug-2022 and 18-aug-2022 (processed together as significant) from a patient.Outcome, start date, hospitalization dates, latency, corrective treatment was updated for event arthritis bacterial and its associated symptoms.Injection date was updated.Batch number was added.Clinical course was updated.Text was amended accordingly.Additional information was received on 18-aug-2022.Batch number was added.Text amended accordingly.Additional information was received on 02-sep-2022: no significant information was received.Additional information was received on 20-sep-2022.Global ptc number and ptc results added.Text amended accordingly.Additional information was received on 26-sep-2022 from the quality department.Expiration date was added.Ptc result date and details was updated.Text amended accordingly.Based on the previously received information, linking of event septic knee/infection got worse and ended up in the hospital for two months was updated from 'arthritis bacterial' to 'arthritis infective nos'.

• 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: 15204018
• MDR Text Key: 297685990
• Report Number: 2246315-2022-00096
• 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: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: BRSL039C
• 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): Hospitalization; Other; Required Intervention
• Patient Sex: Male