MAUDE Adverse Event Report: SYNVISC ONE; MOZ

Lot Number U13021

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

Patient Problems Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)

Event Type  Injury  

Event Description

Pain in left knee [aching (l) knee].Swelling of left knee [swelling of l knee].Redness in left knee [injection site joint redness].Puncture left knee [effusion (l) knee].Case narrative: based on additional ifnromation received on 09-mar-2020, the case initially considered as not reportable was re-assessed as reportable.Also, the reporter causality initially considered as not related was updated to related.Based on additional information received on 27-feb-2020 from healthcare professional the case became medically confirmed.Additionally, the case initially assessed as non-serious was upgraded to serious (intervention required for pain in left knee, swelling of left knee and redness in left knee).Also, the reporter causality initially considered as not reported was re-assessed as not related.This case was linked to case (b)(4) (right knee), (b)(4) (multiple devices for same patient).Initial information received on 19-feb-2020 regarding a solicited valid serious case received from a consumer via call center, in the scope of post-marketing sponsored study "(b)(6)".Patient id: unknown; country: (b)(6).Study title: (b)(6).This case involves an adult female patient who experienced pain in left knee, swelling of left knee and redness in left knee, puncture left knee with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.Patient had left gonarthrosis with chronic synovitis.On (b)(6) 2014, the patient received intra-articular lateral injection of hylan g-f 20, sodium hyaluronate in her left knee at dosage 6ml, frequency once (batch: u13021) for grade 2 gonarthrosis.On an unknown date, after unknown latency, patient experienced pain in left knee, swelling of left knee and redness in left knee (all of moderate intensity).She reported that after the injection her knee swelled up, became red and was painful.Patient mentioned her physician said that she most likely had a reaction to the product.It was reported that this was the only episode probably related to hylan g-f 20, sodium hyaluronate.Patient had some punctures (onset and latency for effusion: unknown) and triamcinolone acetonide (kenalog) infiltration 40 mg.Also, after 3 weeks from injection, patient had cortisone injection.Patient was followed from 2014 to 2018.Patient was reviewed by healthcare professional in (b)(6) 2018 and should try prp (platelet rich plasma) therapy.Action taken: not applicable for all events.Corrective treatment: puncture for effusion left knee (puncture left knee); cortisone injection, triamcinolone acetonide (kenalog), puncture for rest of the events.Outcome: unknown for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 02-mar-2020 for product.Batch number; unknown.Device not returned.The product lot number was not provided; therefore, a batch record review was 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 will continue to monitor adverse events to determine if a capa is required.Final investigation complete date: 11-mar-2020.Reporter causality: related for all events.Company causality: reportable for all events.Additional information was received on 27-feb-2020 from healthcare professional and the case became medically confirmed.Event of puncture right knee was added with details.Corrective treatment updated for redness in left knee, swelling of left knee, pain in left knee.Outcome updated for the same to unknown and reporter causality updated to not related as well.Seriousness criteria added.Batch number added for suspect.Medical history updated.Clinical course updated.Text amended accordingly.Additional information was received on 09-mar-2020 from healthcare professional.Suspect therapy date and corrective treatment updated.Reporter and company causality updated for all events.Related case id added.Clinical course updated.Text amended accordingly.Additional information was received on 11-mar-2020 from healthcare professional.Global ptc number and ptc results added.Text was amended accordingly.

Event Description

Pain in left knee [aching (l) knee], swelling of left knee [swelling of l knee], redness in left knee [injection site joint redness], puncture left knee [effusion (l) knee].Case narrative: based on additional information received on 09-mar-2020, the case initially considered as not reportable was re-assessed as reportable.Also, the reporter causality initially considered as not related was updated to related.Based on additional information received on 27-feb-2020 from healthcare professional the case became medically confirmed.Additionally, the case initially assessed as non-serious was upgraded to serious (intervention required for pain in left knee, swelling of left knee and redness in left knee).Also, the reporter causality initially considered as not reported was re-assessed as not related.This case was linked to case (b)(4) (right knee), (b)(4) (multiple devices for same patient).Initial information received on 19-feb-2020 regarding a solicited valid serious case received from a consumer via call center, 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 an adult female patient who experienced pain in left knee, swelling of left knee and redness in left knee, puncture left knee with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.Patient had left gonarthrosis with chronic synovitis.On (b)(6) 2014, the patient received intra-articular lateral injection of hylan g-f 20, sodium hyaluronate in her left knee at dosage 6ml, frequency once (batch: u13021) for grade 2 gonarthrosis.On an unknown date, after unknown latency, patient experienced pain in left knee, swelling of left knee and redness in left knee (all of moderate intensity).She reported that after the injection her knee swelled up, became red and was painful.Patient mentioned her physician said that she most likely had a reaction to the product.It was reported that this was the only episode probably related to hylan g-f 20, sodium hyaluronate.Patient had some punctures (onset and latency for effusion: unknown) and triamcinolone acetonide (kenalog) infiltration 40 mg.Also, after 3 weeks from injection, patient had cortisone injection.Patient was followed from 2014 to 2018.Patient was reviewed by healthcare professional in (b)(6) 2018 and should try prp (platelet rich plasma) therapy.Action taken: not applicable for all events.Corrective treatment: puncture for effusion left knee (puncture left knee); cortisone injection, triamcinolone acetonide (kenalog), puncture for rest of the events.Outcome: unknown for all events.A product technical complaint was initiated on 27-feb-2020 for synvisc one.Batch number: u13021 global ptc number: (b)(4).The production and quality control documentation for lot u13021 expiration date (2016-05) 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 u13021 no capa is 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 13-mar-2020, a total of 40 complaints had been reported for lot u1302 & all related sub-lots: 8 complaints had been reported for lot u1302 (2 detached luer-lok hub, 1 tip breakage, 1 leaky syringe (2 syringes), 2 adverse event reports, 1 tip breakage (1 syringe)/detached luer-lok hub (2 syringes) & 1 broken plunger rod/damaged lid/damaged tray (1 syringe).30 complaints had been reported for lot u13021 (29 adverse event reports & 1 detached luer-lok hub).2 complaints had been reported for lot u13022 (1 adverse event report & 1 broken plunger rod).Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling쳌 to determine if a capa is required.Final investigation date: 13-mar-2020.Reporter causality: related for all events.Company causality: reportable for all events.Additional information was received on 27-feb-2020 from healthcare professional and the case became medically confirmed.Event of puncture right knee was added with details.Corrective treatment updated for redness in left knee, swelling of left knee, pain in left knee.Outcome updated for the same to unknown and reporter causality updated to not related as well.Seriousness criteria added.Batch number added for suspect.Medical history updated.Clinical course updated.Text amended accordingly.Additional information was received on 09-mar-2020 from healthcare professional.Suspect therapy date and corrective treatment updated.Reporter and company causality updated for all events.Related case id added.Clinical course updated.Text amended accordingly.Additional information was received on 11-mar-2020 from healthcare professional.Global ptc number and ptc results added.Text was amended accordingly.Additional information was received on 13-mar-2020 from other healthcare professional (genzyme event management group).Upon internal review, ptc results updated.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• MDR Report Key: 9853212
• MDR Text Key: 196649039
• Report Number: 2246315-2020-00049
• 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,health professional,s
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/01/2016
• Device Lot Number: U13021
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention