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

Lot Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Infection in the target knee post injection [injection site joint infection].Case narrative: initial information received on 27-dec-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age male patient who had infection in the target knee post injection with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient received synvisc injection in knee via intra-articular route (lot, expiry date, strength, dose,frequency - unknown) for oa(osteoarthritis) knee.Information on batch number was requested.On an unknown date after an unknown latency the patient had infection in the target knee post injection (injection site joint infection) (medically significant).Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

(b)(4) comment dated 28-dec-2022: this case involves an unknown age male patient who had infection in the target knee post injection 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

Infection in the target knee post injection [injection site joint infection].Case narrative: initial information received on 27-dec-2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age male patient who had infection in the target knee post injection with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), family history were not provided.On an unknown date, the patient received synvisc injection in knee via intra-articular route (lot, expiry date, strength, dose,frequency - unknown) for oa(osteoarthritis) knee.Information on batch number was requested.On an unknown date after an unknown latency the patient had infection in the target knee post injection (injection site joint infection) (medically significant).Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.A product technical complaint (ptc) was initiated, and the results were pending for the same.Based on information previously received, imdrf annex e code (joint infection) updated from blank to e1906.

Manufacturer Narrative

Sanofi company comment dated on 28-dec-2022: this case involves an unknown age male patient who had infection in the target knee post injection 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

Infection in the target knee post injection [injection site joint infection] case narrative: initial information received on (b)(6) 2022 from united states regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an unknown age male patient who had infection in the target knee post injection with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), family history were not provided.On an unknown date, the patient received synvisc injection in knee via intra-articular route with strength: 16mg/2ml (lot, expiry date, dose, frequency - unknown) for oa(osteoarthritis) knee.Information on batch number was requested.On an unknown date after an unknown latency the patient had infection in the target knee post injection (injection site joint infection) (medically significant).Action taken: unknown corrective treatment: not reported outcome: unknown a product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample status was not available.Ptc was set in process and results were pending for the same.Based on information previously received, imdrf annex e code (joint infection) updated from blank to e1906.Additional information was received on (b)(6) 2022 from healthcare professional (quality department).Ptc number along with strength were added.Text amended accordingly.

Event Description

Infection in the target knee post injection [injection site joint infection] case narrative: initial information was received on 27-dec-2022 from united states regarding an unsolicited valid serious case from a consumer/non-hcp.This case involves an unknown age male patient who had infection in the target knee post injection with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), family history were not provided.On an unknown date, the patient received synvisc injection in knee via intra-articular route with strength: 16mg/2ml (lot, expiry date, dose, frequency - unknown) for oa (osteoarthritis) knee.Information on batch number was requested.On an unknown date after an unknown latency the patient had infection in the target knee post injection (injection site joint infection) (medically significant).Action taken: unknown corrective treatment: not reported outcome: unknown a product technical complaint (ptc) was initiated on 27-dec-2022 for synvisc (batch number: unknown) with global ptc number 100332806.The sample status was not available and ptc stated: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation ((b)(6)) 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 will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 12-jun-2023 with summarized conclusion as no assessment possible.Based on information previously received, imdrf annex e code (joint infection) updated from blank to e1906 additional information was received on 27-dec-2022 from healthcare professional (quality department).Ptc number along with strength were added.Text amended accordingly.Additional information was received on 12-jun-2023 from quality department: ptc details with summarized conclusion 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: 16066447
• MDR Text Key: 306320871
• Report Number: 2246315-2022-00154
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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
• Patient Sex: Male