MAUDE Adverse Event Report: SYNVISC; MOZ

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Event Description

Mild degree of soft tissue edema [soft tissue swelling], left knee arthroscopy [arthroscopy l knee], pain [pain nos], discomfort [discomfort nos], mild degree of lateral subluxation of the tibia and patella [subluxation knee], instability in the knee having to use a cane to walk.[joint instability], joint effusion [joint effusion], partial medial, lateral meniscectomy [knee meniscectomy], left knee surgery [knee operation], chondroplasty of the medial femoral condyle, trochlea and patella [chondroplasty], mild degenerative changes [unevaluable event], case narrative: initial information received on 29-sep-2020 regarding a solicited valid serious case from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6); country: united states; center id: unknown.Study title: (b)(6).This case involves a (b)(6) years old female patient who experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event), while she using with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, at a dose of 10 ml weekly via subcutaneous route unknown (with an unknown batch number and expiry date) for osteoarthritis.On an unknown date, unknown latency, after initiation of suspect product, the patient had experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (corrective treatment) (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event).It was not reported if the patient received a corrective treatment for other events.Soft tissue swelling was assessed as medically significant as per reporter.Events outcome were unknown, at the time of reporting.Reporter causality: unassessable for all the events with respect to hylan g-f 20, sodium hyaluronate.Company causality was not reportable for all the events with respect to hylan g-f 20, sodium hyaluronate.No further information was provided.

Event Description

Mild degree of soft tissue edema [soft tissue swelling].Left knee arthroscopy [arthroscopy l knee].Pain [pain].Discomfort [discomfort].Mild degree of lateral subluxation of the tibia and patella [subluxation knee].Instability in the knee having to use a cane to walk.[joint instability].Joint effusion [joint effusion].Partial medial, lateral meniscectomy [knee meniscectomy].Left knee surgery [knee operation].Chondroplasty of the medial femoral condyle, trochlea and patella [chondroplasty].Mild degenerative changes [unevaluable event].Case narrative: initial information received on (b)(6) 2020 regarding a solicited valid serious case from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6); country: united states; center id: unknown.Study title: sanofi patient connection.This case involves a 55 year old female patient who experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event), while she using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate 48 mg/6 ml injection, liquid (solution), at a dose of 10 ml weekly via subcutaneous route unknown (with an unknown batch number and expiry date) for osteoarthritis.On an unknown date, (unknown latency) after initiation of suspect product, the patient had experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (corrective treatment) (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event).The event soft tissue swelling was assessed as medically significant as per reporter.Action taken with the suspect drug was not applicable.It was unknown if the patient received a corrective treatment for the events.Events outcome were unknown, at the time of reporting.Reporter causality: unassessable for all the events with respect to hylan g-f 20, sodium hyaluronate.Company causality was not reportable for all the events with respect to hylan g-f 20, sodium hyaluronate.No further information was provided.Additional information regarding a product technical complaint (ptc) was initiated on (b)(6) 2020 for hylan g-f 20, sodium hyaluronate (synvisc one).Batch number and expiration date not reported.Global ptc number: (b)(4) was received on (b)(6) 2020.Sample status: not available.Complaint status: in progress.Strength and formulation of the suspect drug was updated.Corresponding fields and narrative were updated accordingly.

Event Description

Mild degree of soft tissue edema [soft tissue swelling].Left knee arthroscopy [arthroscopy l knee].Pain [pain].Discomfort [discomfort].Mild degree of lateral subluxation of the tibia and patella [subluxation knee].Instability in the knee having to use a cane to walk.[joint instability].Joint effusion [joint effusion].Partial medial, lateral meniscectomy [knee meniscectomy].Left knee surgery [knee operation].Chondroplasty of the medial femoral condyle, trochlea and patella [chondroplasty].Mild degenerative changes [unevaluable event].Case narrative: initial information received on 29-sep-2020 regarding a solicited valid serious case from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6); country: united states; center id: unknown study title: sanofi patient connection.This case involves a 55 year old female patient who experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event), while she using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate 48 mg/6 ml injection, liquid (solution), at a dose of 10 ml weekly via subcutaneous route unknown (with an unknown batch number and expiry date) for osteoarthritis.On an unknown date, (unknown latency) after initiation of suspect product, the patient had experienced mild degree of soft tissue edema (soft tissue swelling), left knee arthroscopy (arthroscopy), pain, discomfort, instability in the knee having to use a cane to walk (corrective treatment) (joint instability), mild degree of lateral subluxation of the tibia and patella (joint dislocation), joint effusion, partial medial, lateral meniscectomy (meniscus removal), left knee surgery (knee operation), chondroplasty of the medial femoral condyle, trochlea and patella (chondroplasty) and mild degenerative changes (unevaluable event).The event soft tissue swelling was assessed as medically significant as per reporter no action was taken with respect to suspect drug.It was unknown if the patient received a corrective treatment for the events.Events outcome were unknown, at the time of reporting.Reporter causality: unassessable for all the events with respect to hylan g-f 20, sodium hyaluronate.Company causality was not reportable for all the events with respect to hylan g-f 20, sodium hyaluronate.No further information was provided.Additional information regarding a product technical complaint (ptc) was initiated on (b)(6) 2020 for hylan g-f 20, sodium hyaluronate (synvisc one).Batch number and expiration date not reported.Global ptc number: 100123059 was received on 29-sep-2020.Sample status: not available.Complaint status: in progress.Strength and formulation of the suspect drug was updated.Corresponding fields and narrative were updated accordingly.Additional information was received on 05-may-2021.A product technical complaint (ptc) was initiated on 29-sep-2020, for hylan g-f 20, sodium hyaluronate (synvisc) (batch number and expiration date: unknown), global ptc number: 100123059.Sample status: not available.Investigation revealed: the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events as stated in sop rdg-sop-000440 product event handling to determine if a capa is required.Final investigation complete date: 05-may-2021 summarized conclusion: no assessment possible.Corresponding fields and narrative were updated accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• MDR Report Key: 10647130
• MDR Text Key: 213859458
• Report Number: 2246315-2020-00141
• 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: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2021; 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention