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

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

Patient Problems Arthralgia (2355); Ambulation Difficulties (2544); Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 13-sep-2022: this case involves a 58 years old female patient who was hospitalised for hard (left knee), unable to walk/couldn't walk, pain/very painful (left knee)/her knee is more painful than before and swelling/swollen left knee (until her foot) after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product was assessed as reportable.However, further information regarding patient¿s medical history, past medications, concomitant medications (in left knee, if any), and other risk factors would aid in better case assessment.

Event Description

Unable to walk/couldn't walk [unable to walk].Swelling/swollen left knee (until her foot) [unilateral leg swelling].Pain/very painful (left knee)/her knee is more painful than before [injection site joint pain] ([condition aggravated]).Swelling/swollen left knee (until her foot) [injection site joint swelling] hard (left knee) [stiff knees].Case narrative: initial information was received on 08-sep-2022 regarding a solicited valid serious case from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc.This case involves a 58 years old female patient who had hard (left knee), unable to walk/couldn't walk, pain/very painful (left knee)/her knee is more painful than before and swelling/swollen left knee (until her foot) while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient had synvisc injections before with no problem.Concomitant medications included two covid-19 vaccines and one booster but did not recall the dates.The first vaccine was astrazeneca and the second vaccine as well as the booster was moderna.In (b)(6) 2022, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection in left knee at dose of 2x2 ml (with an unknown batch number, expiry date, route, strength) for osteoarthritis.Information on batch number was requested.On an unknown date in 2022, after unknown latency, the left knee was swollen (until her foot) (injection site joint swelling, peripheral swelling), hard (joint stiffness), couldn't walk (gait inability), and very painful.She had two out of the three injections and after the second one she ended up in the hospital.Swelling has gone down however her knee is more painful than before (condition aggravated).All events required hospitalization.It was unknown if there were lab data/results available.Action taken: drug withdrawn for all the events.It was not reported if the patient received a corrective treatment for the events at time of reporting, the outcome was recovering for the event swelling/swollen left knee (until her foot); not recovered for rest all events.Reporter causality: unassessable for all the events.Company causality: reportable for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Unable to walk/couldn't walk [unable to walk] swelling/swollen left knee (until her foot) [unilateral leg swelling] pain/very painful (left knee)/her knee is more painful than before [injection site joint pain] ([condition aggravated]) swelling/swollen left knee (until her foot) [injection site joint swelling] hard (left knee) [stiff knees] case narrative: initial information was received on 08-sep-2022 regarding a solicited valid serious case from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada study title: patient support program involving synvisc.This case involves a 58 years old female patient who had hard (left knee), unable to walk/couldn't walk, pain/very painful (left knee)/her knee is more painful than before and swelling/swollen left knee (until her foot) while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient had synvisc injections before with no problem.Concomitant medications included two covid-19 vaccines and one booster but did not recall the dates.The first vaccine was astrazeneca and the second vaccine as well as the booster was moderna.In july 2022, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection in left knee at dose of 2x2 ml having the strength 16mg/2ml (with an unknown batch number, expiry date, route) for osteoarthritis.Information on batch number was requested.On an unknown date in 2022, after unknown latency, the left knee was swollen (until her foot) (injection site joint swelling, peripheral swelling), hard (joint stiffness), couldn't walk (gait inability), and very painful.She had two out of the three injections and after the second one she ended up in the hospital.Swelling has gone down however her knee is more painful than before (condition aggravated).All events required hospitalization.It was unknown if there were lab data/results available.Action taken: drug withdrawn for all the events.It was not reported if the patient received a corrective treatment for the events at time of reporting, the outcome was recovering for the event swelling/swollen left knee (until her foot); not recovered for rest all events reporter causality: unassessable for all the events company causality: reportable for all the events a product technical complaint (ptc) was initiated on 09-sep-2022 for synvisc (lot/batch number: unknown) with global ptc number: 100260053.The sample status of the ptc was not available and the ptc stated the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no corrective action/preventative action (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 non-conformance 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa was required.The final investigation was completed on 13-oct-2022 with summarized conclusion as no assessment possible.Additional information was received 13-oct-2022 from the quality department.Strength and ptc details was added.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 15432823
• MDR Text Key: 300033615
• Report Number: 2246315-2022-00114
• 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,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2022
• 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: ASTRAZENECA COVID-19 VACCINE,UNKNOWN; ASTRAZENECA COVID-19 VACCINE,UNKNOWN; MODERNA COVID-19 VACCINE (ELASOMERAN),UNKNOWN; MODERNA COVID-19 VACCINE (ELASOMERAN),UNKNOWN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female