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 Therapeutic Response, Decreased (2271); Arthralgia (2355); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 10-dec-2020: this case concerns a patient who was on treatment with synvisc one and reported to have surgery for bunion on right foot.Based on available information there is no evidence of the event to occur with device and the event occurrence due to the device is unlikely.However, the information regarding the event's clinical course is very limited, more information regarding the event such as onset date, severity will help in better assessment of the case.

Event Description

Bunion of the right foot [bunion].Thinks that she may have a fissure [anal fissure] ([constipation], [painful defaecation]) can only sleep 4-5 hrs [sleep difficult].If she walks, she feels malaise, but she does not feel pain [malaise].Can only sleep 4-5 hrs after that has to get up and walk because she has lot of pain while lying down/got much worse when she underwent bunion surgery/knee pain returned/very intense knee pain [arthralgia aggravated] ([therapeutic response shortened]).Case narrative: initial information received from (b)(6) on 03-dec-2020 regarding an unsolicited valid serious case received from patient.This case is linked to case (b)(4) (cluster).This case involves a (b)(6) years old female patient who had bunion of the right foot, thinks that she may have a fissure, if she walks, she feels malaise, but she does not feel pain and can only sleep 4-5 hrs after that has to get up and walk because she has lot of pain while lying down/got much worse when she underwent bunion surgery/knee pain returned/very intense knee pain, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and rivaroxaban (xarelto) the patient's past medical history, medical treatment(s), vaccination(s) was not provided.It was reported that patient cannot take anti-inflammatories because she was allergic to them all.She can only take paracetamol (ben-u-ron).This reaction was identified because when patient took anti-inflammatory drugs (she didn't specify which or when or how often) she got itching in her body and there was a drug (she can't remember which one but it was an anti-inflammatory); when she took the second tablet she had to go to the hospital because her glottis was closed and she was unable to breathe anymore.When patient took the medicine diclofenac (voltaren), she could not urinate the whole day.Patient had family history of allergies: patient's son who had asthma had an asthma attack when he took ibuprofen (brufen).Patient had lack of cartilage in her right leg and had a sprain in her left foot (does not remember when).It was reported that patient had bone problems since she was (b)(6), was diagnosed with osteoporosis, a congenital problem.Patient took an unspecified drug to prevent it from getting worse, at the dose of one tablet a week and had to stand for 15 minutes.Concomitant medications included diclofenac (voltaren); paracetamol (ben-u-ron); cortisone; ethyl loflazepate (victan); and sertraline.Patient had been taking sertraline since her husband passed away.Patient had lack of cartilage on the outside of her right knee and started having very intense knee pain in 2020.The doctor told her that she had to put on half a prosthesis or continue with the infiltrations and the infiltrations were only local, and she may return to do another soon.On an unknown date in (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate infiltration (injection) (dose, frequency, route, batch number, indication: unknown).Patient did not know the batch number.Until the injection, patient was with full pain, after taking the injection patient was soon well, without pain, took paracetamol in the first days and after that she no longer needed to take the analgesic, patient felt a relief and improved over time and after 15 days she could run and pedal.The patient was recently operated on the bunion of the right foot on (b)(6) 2020 (foot deformity; onset, latency: unknown, event assessed as serious due to required intervention).The operation went well, and it had healed.Since the operation patient had been taking rivaroxaban tablet (strength: 10 mg) at the dose of 1 tablet, once daily to prevent the formation of thrombosis, as advised and prescribed by the doctor.Patient was indicated to take rivaroxaban for 30 days.Since taking rivaroxaban (on an unknown date in (b)(6) 2020, latency: few months), patient had constipation and felt pain while defecating (dyschezia) and patient even thought that she may have a fissure (anal fissure).Before taking rivaroxaban, patient does not remember having constipation.Patient complained that there was no reimbursement for the medicine and she was told that it would last 6 to 9 months but the drug had a shorter effect than expected (therapeutic response shortened).Patient had not had any knee pain for a long time but she again felt it three days ago (on (b)(6) 2020).If she walked, she felt malaise, but she does not feel pain.She could only sleep 4 to 5 hours, after that period she has to get up and walk because she had lot of pain while lying down (arthralgia, latency: few months).She stopped taking paracetamol as a result of the operation on the bunion and the knee pain returned.Patient stated that knee pain got much worse when she underwent bunion surgery.She usually raised her right leg and puts on an elastic stocking as directed by a doctor and felt better that way.Patient's doctor said that her medical tests which she performed were very good.Action taken: not applicable for all events with respect to hylan g-f 20, sodium hyaluronate, not applicable for foot deformity, unknown for rest of the events with respect to rivaroxaban.Corrective treatment: surgery for foot deformity, raised her right leg and puts elastic stocking for arthralgia, not reported for rest of the events.Outcome: recovered for foot deformity, unknown for rest of the events.A product technical complaint was initiated and results were pending for the same.

Event Description

Bunion of the right foot [bunion].Thinks that she may have a fissure [anal fissure] ([constipation], [painful defaecation]).Can only sleep 4-5 hrs [sleep difficult].If she walks, she feels malaise, but she does not feel pain [malaise].Can only sleep 4-5 hrs after that has to get up and walk because she has lot of pain while lying down/got much worse when she underwent bunion surgery/knee pain returned/very intense knee pain [arthralgia aggravated] ([therapeutic response shortened]).Case narrative: initial information received from portugal on 03-dec-2020 regarding an unsolicited valid serious case received from patient.This case is linked to case (b)(4) (cluster).This case involves a 74 years old female patient who had bunion of the right foot, thinks that she may have a fissure, if she walks, she feels malaise, but she does not feel pain and can only sleep 4-5 hrs after that has to get up and walk because she has lot of pain while lying down/got much worse when she underwent bunion surgery/knee pain returned/very intense knee pain, while she was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and rivaroxaban (xarelto).The patient's past medical history, medical treatment(s), vaccination(s) was not provided.It was reported that patient cannot take anti-inflammatories because she was allergic to them all.She can only take paracetamol (ben-u-ron).This reaction was identified because when patient took anti-inflammatory drugs (she didn't specify which or when or how often) she got itching in her body and there was a drug (she can't remember which one but it was an anti-inflammatory); when she took the second tablet she had to go to the hospital because her glottis was closed and she was unable to breathe anymore.When patient took the medicine diclofenac (voltaren), she could not urinate the whole day.Patient had family history of allergies: patient's son who had asthma had an asthma attack when he took ibuprofen (brufen).Patient had lack of cartilage in her right leg and had a sprain in her left foot (does not remember when).It was reported that patient had bone problems since she was 38, was diagnosed with osteoporosis, a congenital problem.Patient took an unspecified drug to prevent it from getting worse, at the dose of one tablet a week and had to stand for 15 minutes.Concomitant medications included diclofenac (voltaren); paracetamol (ben-u-ron); cortisone; ethyl loflazepate (victan); and sertraline.Patient had been taking sertraline since her husband passed away.Patient had lack of cartilage on the outside of her right knee and started having very intense knee pain in 2020.The doctor told her that she had to put on half a prosthesis or continue with the infiltrations and the infiltrations were only local, and she may return to do another soon.On an unknown date in (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate infiltration (injection) (dose, frequency, route, batch number, indication: unknown).Patient did not know the batch number.Until the injection, patient was with full pain, after taking the injection patient was soon well, without pain, took paracetamol in the first days and after that she no longer needed to take the analgesic, patient felt a relief and improved over time and after 15 days she could run and pedal.The patient was recently operated on the bunion of the right foot on (b)(6) 2020 (foot deformity; onset, latency: unknown, event assessed as serious due to required intervention).The operation went well, and it had healed.Since the operation patient had been taking rivaroxaban tablet (strength: 10 mg) at the dose of 1 tablet, once daily to prevent the formation of thrombosis, as advised and prescribed by the doctor.Patient was indicated to take rivaroxaban for 30 days.Since taking rivaroxaban (on an unknown date in (b)(6) 2020, latency: few months), patient had constipation and felt pain while defecating (dyschezia) and patient even thought that she may have a fissure (anal fissure).Before taking rivaroxaban, patient does not remember having constipation.Patient complained that there was no reimbursement for the medicine and she was told that it would last 6 to 9 months but the drug had a shorter effect than expected (therapeutic response shortened).Patient had not had any knee pain for a long time but she again felt it three days ago (on (b)(6) 2020).If she walked, she felt malaise, but she does not feel pain.She could only sleep 4 to 5 hours, after that period she has to get up and walk because she had lot of pain while lying down (arthralgia, latency: few months).She stopped taking paracetamol as a result of the operation on the bunion and the knee pain returned.Patient stated that knee pain got much worse when she underwent bunion surgery.She usually raised her right leg and puts on an elastic stocking as directed by a doctor and felt better that way.Patient's doctor said that her medical tests which she performed were very good.Action taken: not applicable for all events with respect to hylan g-f 20, sodium hyaluronate, not applicable for foot deformity, unknown for rest of the events with respect to rivaroxaban.Corrective treatment: surgery for foot deformity, raised her right leg and puts elastic stocking for arthralgia, not reported for rest of the events.Outcome: recovered for foot deformity, unknown for rest of the events.A product technical complaint (ptc) was initiated on 03-dec-2020 for synvisc one (lot number unknown) with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review is 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 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.Sanofi would continue to monitor complaints as to determine if a capa was required.Final investigation was completed on (b)(6) 2020.Additional information was received on 14-dec-2020 from other healthcare professional.Ptc results received and processed.Global ptc number was added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10990509
• MDR Text Key: 223063796
• Report Number: 2246315-2020-00166
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEN-U-RON (PARACETAMOL),UNKNOWN; BEN-U-RON (PARACETAMOL),UNKNOWN; CORTISONE (CORTISONE),INJECTION; CORTISONE (CORTISONE),INJECTION; SERTRALINE (SERTRALINE),TABLET; SERTRALINE (SERTRALINE),TABLET; VICTAN (ETHYL LOFLAZEPATE),TABLET; VICTAN (ETHYL LOFLAZEPATE),TABLET; VOLTAREN [DICLOFENAC] (DICLOFENAC),UNKNOWN; VOLTAREN [DICLOFENAC] (DICLOFENAC),UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR