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 Ambulation Difficulties (2544); 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, knees became swollen, swelling of r knee, 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 right 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.

Manufacturer Narrative

Sanofi company comment on (b)(6) 2021: based on the limited information provided regarding this case, causal role of the company suspect product i. E. Hylan g-f 20, sodium hyaluronate in causing unable to walk, joint swelling and arthrocentesis cannot be established. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Manufacturer Narrative

Sanofi company comment on (b)(6) 2021: based on the limited information provided regarding this case, causal role of the company suspect product i. E. Hylan g-f 20, sodium hyaluronate in causing unable to walk, joint swelling and arthrocentesis cannot be established. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Was not able to walk, knees became swollen, swelling of r knee, 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 right 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: 12879386
• MDR Text Key: 285233083
• Report Number: 2246315-2021-00176
• 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: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 11/30/2021
• Device Lot Number: 9RSL001ZE
• 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 Treatment Data

Date Received: 11/26/2021 Patient Sequence Number: 1