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 Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Infection at one knee [joint infection].Case narrative: upon internal review on 27-nov-2018, the following changes were made in the case, this batch was identified in context of aegis ime functionality specificity and concerns the seriousness of event infection at one knee which was amended from non-serious to serious (important medical event) because included in the ime list.This unsolicited case from (b)(6) was received on (b)(6) 2018 from a healthcare professional.This case involves a (b)(6) female patient who received treatment with synvisc one and had infection at one knee.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2018, the patient initiated treatment with intra-articular synvisc one injection (batch/lot number and expiry date: not provided) once at a dose of 6 ml into knees for osteoarthritis in knees.On an unknown date, few days after injection the patient complained of infection in one knee and visited the physician.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.A global pharmaceutical technical complaint was initiated and ptc results were pending for the same.Seriousness criteria: medically significant for infection at one knee upon internal review on 27-nov-2018, the event of infection at one knee was updated from non-serious to serious (seriousness criteria: medically significant) and the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.

Event Description

Infection at one knee [joint infection].Case narrative: upon internal review on (b)(6) 2018, the following changes were made in the case, this batch was identified in context of aegis ime functionality specificity and concerns the seriousness of event infection at one knee which was amended from non-serious to serious (important medical event) because included in the ime list.This unsolicited case from bangladesh was received on 12-jul-2018 from a healthcare professional.This case involves a 68 years old female patient who received treatment with synvisc one and had infection at one knee.No past drug, medical history, concomitant medication or concurrent condition was provided.On (b)(6) 2018, the patient initiated treatment with intra-articular synvisc one injection (batch/lot number and expiry date: not provided) once at a dose of 6 ml into knees for osteoarthritis in knees.On an unknown date, few days after injection the patient complained of infection in one knee and visited the physician.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.A global pharmaceutical technical complaint was initiated and ptc results were pending for the same.Seriousness criteria: medically significant for infection at one knee upon internal review on (b)(6) 2018, the event of infection at one knee was updated from non-serious to serious (seriousness criteria: medically significant) and the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.Upon internal review on (b)(6)2019 with the clock start date of (b)(6)2018 the device malfunction incorrectly captured as 'yes' was corrected.

Event Description

Infection at one knee [joint infection].Case narrative: upon internal review on 27-nov-2018, the following changes were made in the case, this batch was identified in context of aegis ime functionality specificity and concerns the seriousness of event infection at one knee which was amended from non-serious to serious (important medical event) because included in the ime list.This unsolicited case from (b)(6) was received on 12-jul-2018 from a healthcare professional.This case involves a 68 years old female patient who received treatment with synvisc one and had infection at one knee.No past drug, medical history, concomitant medication or concurrent condition was provided.On 28-jun-2018, the patient initiated treatment with intra-articular synvisc one injection (batch/lot number and expiry date: not provided) once at a dose of 6 ml into knees for osteoarthritis in knees.On an unknown date, few days after injection the patient complained of infection in one knee and visited the physician.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.A ptc (product technical complaint) was initiated on 02-aug-2018 for synvisc one (with batch number: unknown) with global ptc number: (b)(4).The product lot number was not provided; a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review batch records for specification conformance prior to release.Any out of specification result was identified and mitigation through ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assess possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The review had not indicated any safety issue.The final investigation was completed: 02-aug-2018.Seriousness criteria: medically significant for infection at one knee.Upon internal review on 27-nov-2018, the event of infection at one knee was updated from non-serious to serious (seriousness criteria: medically significant) and the reporter causality was updated from not reported to related.Clinical course was updated and text was amended accordingly.Upon internal review on 09-jan-2019 with the clock start date of 12-jul-2018 the device malfunction incorrectly captured as 'yes' was corrected.Additional information was received on 02-aug-2018 from the quality department.Global ptc number added and text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8200722
• MDR Text Key: 131915210
• Report Number: 2246315-2018-00843
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: BG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

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 Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/07/2019; 07/12/2022
• 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; Other
• Patient Age: 68 YR
• Patient Sex: Male