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

Lot Number UNKNOWN

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/01/2020

Event Type  Injury  

Event Description

Surgery: it didn't work at all, no relief for my two knees/lack of efficacy [device ineffective].Case narrative: initial information received on (b)(6) 2022 from canada regarding an unsolicited valid social media serious case received from a consumer/non-hcp.This case involves an unknown age and unknown gender patient who had surgery and it didn't work at all, no relief for my two knees/lack of efficacy with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included cortisone.The patient's past medical history, vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing arthrosis.On an unknown date, the patient received synvisc injection in her first knee (lot, expiry date, strength, frequency, dose) for severe arthrosis.After several years with cortisone, the orthopedist suggested synvisc.On an unknown date after an unknown latency it didn't work at all, no relief for my two knees/lack of efficacy (device ineffective) (severe arthrosis) more than $1000 lost.Had (surgery) (required intervention and medically significant) 18 months ago, now have 2 brand new knees.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the events (surgery).At time of reporting, the outcome was unknown for the event it didn't work at all, no relief for my two knees/lack of efficacy and was unknown for the event surgery.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2022: this case involves an unknown age and unknown gender patient who had surgery and it didn't work at all, no relief for my two knees/lack of efficacy with 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 could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Surgery/now have 2 brand new knees [total knee replacement] it didn't work at all, no relief for my two knees/lack of efficacy [device ineffective] case narrative: this case is linked to case (b)(4) (multiple devices suspect for same patient).Initial information was received on 28-sep-2022 from canada regarding an unsolicited valid social media serious case from a patient.This case involves an unknown age and unknown gender patient who had surgery/now have 2 brand new knees and it didn't work at all, no relief for my two knees/lack of efficacy with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included cortisone.The patient's past medical history, vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing arthrosis.On an unknown date, the patient received hylan g-f 20, sodium hyaluronate (synvisc, 16 mg/2ml) injection, liquid solution, in her first knee (lot, expiry date, frequency, dose, route: unknown) for severe arthrosis.Information on batch number was requested.After several years with cortisone, the orthopedist suggested synvisc.On an unknown date after an unknown latency, it didn't work at all, no relief for my two knees/lack of efficacy (device ineffective) (severe arthrosis) more than $(b)(6) lost.The patient had surgery (knee arthroplasty, medically significant) 18 months ago ((b)(6) 2020), now had 2 brand new knees.Action taken: not applicable for both the events it was not reported if the patient received a corrective treatment for the events at time of reporting, the outcome was unknown for both the events product technical complaint (ptc) was initiated with global ptc number (b)(4) on 28-sep-2022 for synvisc.Batch number: unknown.The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without product 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 is required.The final investigation was completed on 03-nov-2022 with summarized conclusion as no assessment possible.Additional information was received on 03-nov-2022 from other healthcare professional (from quality department).Gptc results were received and added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• 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: 15538522
• MDR Text Key: 301125636
• Report Number: 2246315-2022-00122
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• 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
• Patient Outcome(s): Other; Required Intervention