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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Pain (1994); Anxiety (2328); Disability (2371); No Code Available (3191)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment 17-dec-2019.This case concerns a patient who received treatment with synvisc one from the recall lot and later experienced infection and physical impairment.Temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

Event Description

Immediate adverse reaction and subsequent infection [joint infection], disfigurement/physical impairment [physical impairment], device malfunction [device malfunction], injuries [injury nos], physical pain [pain], mental anguish [anguish].Case narrative: this case was found to be duplicate of case: (b)(4) (duplicate).Initial information received on 11-dec-2019 from united states regarding an unsolicited valid serious legal case received from a lawyer.This case involves an unknown age male patient who experienced immediate adverse reaction and subsequent infection (latency: unknown), disfigurement/physical impairment (latency: unknown), injuries (latency: unknown), physical pain (latency: unknown) and mental anguish (latency: unknown), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was also added for the identified recall lot.The patient's past medical history included osteoarthritis of his knee.The past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.On (b)(6) 2017, the patient who received intra-articular injection of hylan g-f 20, sodium hyaluronate at dosage 1 df, frequency once (batch: 7rsl021) for knee pain which was administered by a healthcare professional.On an unknown date in (b)(6) 2017, after the injection, patient suffered an immediate adverse reaction and subsequent infection (latency: unknown) which eventually resulted in several surgeries, months of therapy and numerous hospitalizations.This event was assessed as serious and led to hospitalization and was medically significant.The manufacturing process resulting in the microbial infestation of the concerned batch number was a producing cause of the injuries (latency: unknown) sustained by the patient and resulted in significant harm.Since the injection, patient experienced physical pain (latency: unknown) (onset: (b)(6) 2017) and mental anguish (latency: unknown) (onset: (b)(6) 2017).During the same time, patient also experienced disfigurement/physical impairment (latency: unknown).This event was assessed as serious and resulted in disability.Action taken: not applicable for all events.Corrective treatment: several surgeries and months of therapy for immediate adverse reaction and subsequent infection; not reported for rest of the events.Outcome: unknown for all events.An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from us market for synvisc-one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.

• 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: 9516756
• MDR Text Key: 186825763
• Report Number: 2246315-2019-00316
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2019
• 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): Hospitalization; Other; Disability