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

Lot Number 7RSL044

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

Patient Problems Arthritis (1723); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Disability (2371)

Event Date 05/10/2018

Event Type  malfunction  

Event Description

Lower legs swollen [swelling of legs].Could not walk/ trouble walking [unable to walk].Could barely stand [difficulty in standing].Pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful [pain in leg], ([shooting pain]).Osteoarthritis was worse was synvisc one injection [device ineffective].Area was aspirated [knee effusion].Knee felt like cement [joint stiffness].Knees were swollen like cauliflower [knee swelling].Knees painful [knee pain].Case narrative: based on information received on 11-oct-2018, the reporter causality of all events was updated to related.Initial information received on (b)(6) 2018 regarding an unsolicited valid serious case from unites states received via a consumer.This case involves a (b)(6) years old female patient who could not walk, could barely stand, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15", area was aspirated (knee effusion), knee felt like cement (joint stiffness) and knees were swollen like cauliflower (latency: 0 day for all), osteoarthritis was worse was synvisc one injection (latency: unknown), lower leg swelling (latency- 4 hours), knees painful (unknown latency) after administration of hylan-g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included drug hypersensitivity with to bactrim and levaquin.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, patient received intra-articular injection of synvisc one in both knees (lot - 7rsl044, 21-oct-2020; dose: not reported) for osteoarthritis.On the same day, after four hours, patient experienced that his knees were swollen like cauliflower, felt like cement.The lower legs were swollen and painful.The patient was told to elevate knees and put ice packs on them.The same day, the patient could not walk and could barely stand.Reportedly, the patient tried ice, naproxen sodium (aleve), paracetamol (tylenol) and more ice.The patient went to acute care and was sent to the emergency department (ed).Later, she was admitted to the hospital for 2 days and was given a non-steroid iv and pain medication.On (b)(6) 2018, the pain was "shooting up and down both legs".She states that out of a 0 to 10 pain level, she had a "15" and couldn't stand it.It was later reported that her pain level is doing pretty well.By (b)(6) 2018, the pain was unbearable and the patient had trouble walking and the patient was admitted to the hospital.Patient went back in two weeks and the area was aspirated and cortisone was injected.Patient's osteoarthritis was worse after the synvisc-one injection.Caller denied any infection; they did blood cultures at the hospital but did not aspirate when she was there in the hospital.Later, she could walk.The patient stated that this ruined two weeks out of her life and she was most concerned about being in the hospital.The patient recovered from could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful, knees were swollen like cauliflower 2 weeks after the synvisc was administered.She reported that she was scared that she had cancer or something.On (b)(6) 2018, the patient had x-ray that showed knees bone to bone, her blood work showed high white blood count.Final diagnosis was knee felt like cement, knees were swollen like cauliflower, osteoarthritis was worse was synvisc one injection, area was aspirated, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15", could barely stand and could not walk, lower leg swelling.Corrective treatment: ice, naproxen sodium (aleve), paracetamol (tylenol) and cortisone injection for swollen like cauliflower, knee felt like cement, (latency: 0 day); could not walk, could barely stand, pain was "shooting up and down both legs/out of a 0 to 10 pain level and condition aggravated and ice, non-steroid iv and pain medication for unable to walk and couldn't not stand; naloxone, benadryl, norca, zofran, vancomycin, ketorolac.Outcome: recovered for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful, knees were swollen like cauliflower; unknown for rest of the events.Seriousness criteria: hospitalization for all events a product technical complaint was initiated on 07-jun-2018 for synvisc one, batch number: 7rsl044, global (b)(4).The production and quality control documentation for lot # 7rsl044 expiration date (2020-10-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl044 no capa was 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 had not indicated any safety issue.As of 07-jun-2018 there are 7 complaints on file for lot # 7rsl044: (7) adverse event reports.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440? product complaint handling? to determine if a capa is still required.Additional information was received on 07-jun-2018.Global ptc number was added and ptc results were updated.Additional information was received on (b)(6) 2018 from patient.Additional event of knees painful, lower legs swollen added.Verbatim updated for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful.Outcome updated for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful, knees were swollen like cauliflower.Verbatim updated for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful.Medical history added and concomitant medication added.Lab added.Clinical course was updated and text amended accordingly.

Event Description

Lower legs swollen [swelling of legs].Could not walk/ trouble walking [unable to walk].Could barely stand [difficulty in standing].Pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful [pain in leg] ([shooting pain]).Osteoarthritis was worse was synvisc one injection [device ineffective].Area was aspirated [knee effusion].Knee felt like cement [joint stiffness].Knees were swollen like cauliflower [knee swelling].Knees painful [knee pain].Case narrative: based on information received on 11-oct-2018, the reporter causality of all events was updated to related.Initial information received on 31-may-2018 regarding an unsolicited valid serious case from unites states received via a consumer.This case involves a 68 years old female patient who experienced lower legs swollen, could not walk/ trouble walking, could barely stand, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful, osteoarthritis was worse was synvisc one injection, area was aspirated, knee felt like cement, knees were swollen like cauliflower and knees painful while being treated with with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included drug hypersensitivity with to bactrim and levaquin.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medications included famotidine (pepcid [famotidine]); and piroxicam (paxil [piroxicam]) for anxiety.On (b)(6) 2018, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate) injection dosage unknown (lot - 7rsl044, expiry 31-oct-2020) for osteoarthritis.On the same day, after four hours, patient experienced that his knees were swollen like cauliflower (peripheral swelling) (unknown latency), felt like cement (joint stiffness).The lower legs were swollen and painful (peripheral swelling) (unknown latency).The patient was told to elevate knees and put ice packs on them.The same day, the patient could not walk and could barely stand (gait inability) (dysstasia) (unknown latency).Reportedly, the patient tried ice, naproxen sodium (aleve), paracetamol (tylenol) and more ice.The patient went to acute care and was sent to the emergency department (ed).Later, she was admitted to the hospital for 2 days and was given a non-steroid iv and pain medication.On (b)(6) 2018, the pain was "shooting up and down both legs".She states that out of a 0 to 10 pain level, she had a "15" and couldn't stand it(pain in extremity)(pain) (latency 4 days).It was later reported that her pain level is doing pretty well.By (b)(6) 2018, the pain was unbearable and the patient had trouble walking and the patient was admitted to the hospital.Patient went back in two weeks and the area was aspirated (joint effusion) (unknown latency) and cortisone was injected.Patient's osteoarthritis was worse after the synvisc-one injection (device ineffective) (unknown latency).Caller denied any infection; they did blood cultures at the hospital but did not aspirate when she was there in the hospital.Later, she could walk.The patient stated that this ruined two weeks out of her life and she was most concerned about being in the hospital.The patient recovered from could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful, knees were swollen like cauliflower 2 weeks after the synvisc was administered.She reported that she was scared that she had cancer or something.On 15-may-2018, the patient had x-ray that showed knees bone to bone, her blood work showed high white blood count.Relevant laboratory test results included: haematology test - on (b)(6) 2018: [white blood count high].X-ray - on (b)(6) 2018: [knees bone on bone].Action taken: not applicable for all events.Corrective treatment: ice, naproxen sodium (aleve), paracetamol (tylenol) and cortisone injection for swollen like cauliflower, knee felt like cement, (latency: 0 day); could not walk, could barely stand, pain was "shooting up and down both legs/out of a 0 to 10 pain level and condition aggravated and ice, non-steroid iv and pain medication for unable to walk and couldn't not stand; naloxone, benadryl, norca, zofran, vancomycin, ketorolac.Outcome: recovered for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful, knees were swollen like cauliflower; unknown for rest of the events.Seriousness criteria: hospitalization for all events.A product technical complaint was initiated on 07-jun-2018 for synvisc one, batch number: 7rsl044, global ptc number (b)(4).The production and quality control documentation for lot # 7rsl044 expiration date (2020-10-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl044 no capa was 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 had not indicated any safety issue.As of 07-jun-18 there are 7 complaints on file for lot # 7rsl044: (7) adverse event reports.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440? product complaint handling? to determine if a capa is still required.Additional information was received on 07-jun-2018.Global ptc number was added and ptc results were updated.Additional information was received on 11-oct-2018 from patient.Additional event of knees painful, lower legs swollen added.Verbatim updated for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful.Outcome updated for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful, knees were swollen like cauliflower.Verbatim updated for could not walk/ trouble walking, pain was "shooting up and down both legs/out of a 0 to 10 pain level, she had a "15"/lower legs painful.Medical history added and concomitant medication added.Lab added.Clinical course was updated and text amended accordingly.Based on the information previously received, the reportable malfunction was updated from yes to no in product-device tab.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8158128
• MDR Text Key: 130638341
• Report Number: 2246315-2018-00721
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/31/2020
• Device Lot Number: 7RSL044
• Was Device Available for Evaluation?: 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
• Treatment: PAXIL [PIROXICAM] (PIROXICAM).; PAXIL [PIROXICAM] (PIROXICAM).; PEPCID [FAMOTIDINE] (FAMOTIDINE).; PEPCID [FAMOTIDINE] (FAMOTIDINE).
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 86 KG