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

Lot Number UNKNOWN

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

Patient Problems Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Knee swelled [injection site joint swelling] , had to be punctured after a few days [arthrocentesis] , limited movement [mobility decreased] , tension [joint stiffness].Case narrative: initial information received on (b)(6) 2023 regarding an unsolicited valid serious case received from a consumer/non-hcp from germany.This case involves male patient of unknown age who experienced that his knee swelled, had to be punctured after a few days, had limited movement and tension 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) and family history were not provided.On (b)(6) 2023, the patient started using hylan g-f 20, sodium hyaluronate injection (dosage, batch number, expiry date, indication: unknown) for once only via intra-articular route.Information for batch number and expiry date requested.On the unknown date of 2023, after the latency of few days, patient had knee swelled (injection site joint swelling) and had to be punctured after a few days (aspiration joint).This led to limited movement (mobility decreased) and tension (joint stiffness) relevant laboratory test results included: aspiration joint - in 2023: [results: unknown] corrective treatment: arthrocentesis for knee swelled; not reported for rest all the events.Outcome: unknown for all the events.Seriousness criteria: intervention required for aspiration joint and injection site joint swelling.

Event Description

Knee swelled [injection site joint swelling].Had to be punctured after a few days [arthrocentesis].Limited movement [mobility decreased].Tension [joint stiffness].Case narrative: initial information received on 20-nov-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp from germany.This case involves male patient of unknown age who experienced that his knee swelled, had to be punctured after a few days, had limited movement and tension 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) and family history were not provided.On (b)(6) 2023 the patient started using hylan g-f 20, sodium hyaluronate injection of strength: 48 mg/6 ml(dosage, batch number, expiry date, indication: unknown) for once only via intra-articular route.Information for batch number and expiry date requested.On the unknown date of 2023, after the latency of few days, patient had knee swelled (injection site joint swelling) and had to be punctured after a few days (aspiration joint).This led to limited movement (mobility decreased) and tension (joint stiffness).Relevant laboratory test results included: aspiration joint - in 2023: [results: unknown].Corrective treatment: arthrocentesis for knee swelled; not reported for rest all the events.Outcome: unknown for all the events.Seriousness criteria: intervention required for aspiration joint and injection site joint swelling.A product technical complaint (ptc) was initiated on 20-nov-2023 for synvisc one.Batch number; unknown global ptc number: (b)(4).Sample status of ptc was not available, and ptc stated preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.(b)(4) 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.(em 21nov2023) investigation (em 27nov2023) the product lot number was not provided.A batch record review was 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 actions) was required.The final investigation was completed on 28-nov-2023 with summarized conclusion as no assessment possible.Additional information was received on 28-nov-2023 by quality department from other health care professional: ptc complete details added; strength added; text amended.

• Brand Name: SYNVISC ONE
• 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: 18204948
• MDR Text Key: 328920433
• Report Number: 2246315-2023-00109
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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): Required Intervention
• Patient Sex: Male