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

Lot Number 9RSL001ZE

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 12/01/2020

Event Type  Injury  

Event Description

Was not able to walk, her knees became swollen, knees drained arthrocentesis. Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one". Patient id: (b)(6); country: (b)(6), study title: patient support program involving synvisc one. This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained 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) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze) for osteoarthritis in left knee. On the dec-2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability). Her knee was drained (aspiration joint). Action taken: not applicable for all the events. Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events. Outcome: recovered for all the events. Reporter causality: related for all the events. Company causality: reportable for all the events.

Event Description

Was not able to walk, her knees became swollen, knees drained arthrocentesis. Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon i synvisc one". Patient id: (b)(6); country: (b)(6), study title: patient support program involving synvisc one. This case involves a (b)(6)female patient who was not able to walk, her knees became swollen and her knees drained 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) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection at the dosage of 6 ml for once only via unknown route (lot - 9rsl001ze) for osteoarthritis in left knee. On the (b)(6) 2020, after the latency of two weeks of starting the treatment with hylan g-f 20, sodium hyaluronate, her knee became swollen (joint swelling) and was not able to walk (gait inability). Her knee was drained (aspiration joint). Action taken: not applicable for all the events. Corrective treatment: not reported for aspiration joint; arthrocentesis for rest both the events. Outcome: recovered for all the events. Reporter causality: related for all the events. Company causality: reportable for all the events.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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: 12876021
• MDR Text Key: 285177601
• Report Number: 2246315-2021-00175
• 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,Study,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/01/2021
• Device Lot Number: 9RSL001ZE
• 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 Treatment Data

Date Received: 11/25/2021 Patient Sequence Number: 1