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

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

Patient Problems Bacterial Infection (1735); No Code Available (3191)

Event Date 03/13/2018

Event Type  Injury  

Event Description

This unsolicited case was received from united states on (b)(6) 2018 from a nurse.This case involves a (b)(6) years old male patient who received treatment with synvisc one and the few days after experienced his culture showing abiotrophia and granulicatella, surgery to place an antibiotic spacer, increased pain, swelling, 2 aspirations of the affected knee and left knee was injected and alos received several cortisone injections to that knee (off label use).Patient has a history of atrial fibrillation, prostate cancer, and pulmonary vein stenosis.Concomitant medication included cortisone.No past drugs or concurrent condition was reported.On an unknown date in (b)(6) 2018, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (route, batch/ lot number and expiration date: not provided) for osteoarthritis.Patient's left knee had been injected and that he had also received several cortisone injections to that knee (off label use).On an unknown date in 2018, few days after the first infusion, the patient.On (b)(6) 2018, few days after the first injection, the patient had surgery to place an antibiotic spacer.Patient received iv antibiotic therapy, unspecified.On an unknown date in 2018, few days after the first injection, the patient experienced increased pain and swelling.On an unknown date in 2018, few days after the first injection, the patient's 2 aspirations of the affected knee and culture showing abiotrophia and granulicatella.It was reported the infection was a "rare bug".Patient was seeing infectious disease specialist.Corrective treatment: iv antibiotic therapy for culture showing abiotrophia and granulicatella; aspiration for 2 aspirations of the affected knee; not reported for rest of the events outcome: unknown for his culture showing abiotrophia and granulicatella, surgery to place an antibiotic spacer, increased pain, swelling and 2 aspirations of the affected knee and left knee was injected seriousness criteria: required intervention for culture showing abiotrophia and granulicatella; important medical event for surgery to place an antibiotic spacer a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018.This case concerns a patient who received treatment with synvisc one and later experienced bacterial infection in the knee.Since events occurred in close approximation to the administration of synvisc one injection, therefore, causal role of suspect product cannot be denied in occurrence of the event.Further information regarding medical history, concurrent condition and past drugs will aid in complete medical assessment of the case.

Event Description

Culture showing abiotrophia and granulicatella/knee infection [arthritis bacterial] ([bacterial culture positive], [knee pain], [swelling of l knee], [joint effusion]) left knee was injected and alos received sveral cortisone injections to that knee [off label use] case narrative: based on additional information received on 29-may-2018 this case became medically confirmed.This unsolicited case was received from united states on 06-apr-2018 from a nurse.This case involves a 64 years old male patient who received treatment with synvisc one and the few days after culture showed abiotrophia and granulicatella/knee infection and left knee was injected and also received several cortisone injections to that knee (off label use).Patient has a history of atrial fibrillation which was treated with ablation, prostate cancer, pulmonary vein stenosis which was treated with stent placement and gerd.Concomitant medication included cortisone, ranitidine, aspirin and meloxicam.It was reported that the patient didn't have any known drug allergy and is allergic to shellfish (shellfish-swelling).No past drugs or concurrent condition was reported.On an unknown date in feb-2018 (unsure of date, given the week of 26-feb-2018), the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/ lot number and expiration date: not provided) in left knee for osteoarthritis of left knee.Patient's had also received several cortisone injections to that knee (off label use).On 13-mar-2018, few days after the first injection, the patient experienced increased pain and swelling.Patient was seen in office for knee pain.On the same day, knee was aspirated and fluid was sent for culture.On the same day, result was positive for abiotrophia and granulicatella species.On 19-mar-2018, patient had second knee aspiration culture and the result was abiotrophia and granulicatella species.On 28-mar-2018, he had surgery of knee infection with placement of articulating antibiotic spacer.Patient was currently undergoing iv antibiotic treatment.Corrective treatment: iv antibiotic therapy, surgery and articulating antibiotic spacer for culture showing abiotrophia and granulicatella/knee infection outcome: not recovered for culture showing abiotrophia and granulicatella/knee infection reporter's causality: unsure seriousness criteria: required intervention, medically significant and hospitalization for culture showing abiotrophia and granulicatella a pharmaceutical technical complaint (ptc) was initiated with global ptc number 53448 and results were received for the same.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.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 ncr process.Sanofi global pharmacovigilance and epidemiology 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.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 11-apr-2018.Ptc results and global ptc number was added.Clinical course updated and text amended accordingly.Additional information was received on 29-may-2018 from nurse.Indication of synvisc one was updated from osteoarthritis to osteoarthritis left knee.Event term was updated from culture showing abiotrophia and granulicatella/knee infection, event onset date was added and outcome was updated from unknown to not recovered.Patient's medical conditions and concomitant medication was added.Hospitalization was added as seriousness criteria.Bacterial test positive was added as symptom.Clinical course was updated and text was amended accordingly.

Event Description

This unsolicited case was received from united states on 06-apr-2018 from a nurse.This case involves a 64 years old male patient who received treatment with synvisc one and the few days after experienced his culture showing abiotrophia and granulicatella, surgery to place an antibiotic spacer, increased pain, swelling, 2 aspirations of the affected knee and left knee was injected and alos received several cortisone injections to that knee (off label use).Patient has a history of atrial fibrillation, prostate cancer, and pulmonary vein stenosis.Concomitant medication included cortisone.No past drugs or concurrent condition was reported.On an unknown date in (b)(6) 2018, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (route, batch/ lot number and expiration date: not provided) for osteoarthritis.Patient's left knee had been injected and that he had also received several cortisone injections to that knee (off label use).On an unknown date in 2018, few days after the first infusion, the patient.On (b)(6) 2018, few days after the first injection, the patient had surgery to place an antibiotic spacer.Patient received iv antibiotic therapy, unspecified.On an unknown date in 2018, few days after the first injection, the patient experienced increased pain and swelling.On an unknown date in 2018, few days after the first injection, the patient's 2 aspirations of the affected knee and culture showing abiotrophia and granulicatella.It was reported the infection was a "rare bug".Patient was seeing infectious disease specialist.Corrective treatment: iv antibiotic therapy for culture showing abiotrophia and granulicatella; aspiration for 2 aspirations of the affected knee; not reported for rest of the events outcome: unknown for his culture showing abiotrophia and granulicatella, surgery to place an antibiotic spacer, increased pain, swelling and 2 aspirations of the affected knee and left knee was injected seriousness criteria: required intervention for culture showing abiotrophia and granulicatella; important medical event for surgery to place an antibiotic spacer a pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) and results were received for the same.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.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 ncr process.Sanofi global pharmacovigilance and epidemiology 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.This review has not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Additional information was received on 11-apr-2018.Ptc results and global ptc number was added.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 11-apr-2018.The follow up information received does not change the previous case assessment.Since events occurred in close approximation to the administration of product, therefore, causal role of suspect product cannot be denied in occurrence of the event.Further information regarding medical history, concurrent condition and past drugs will aid in complete medical assessment of the case.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7446094
• MDR Text Key: 106009865
• Report Number: 2246315-2018-00455
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 04/11/2018; 04/11/2018
• Supplement Dates FDA Received: 05/02/2018; 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN [ACETYLSALICYLIC ACID],UNKNOWN; CORTISONE (CORTISONE),UNKNOWN; CORTISONE(CON.); CORTISONE(CON.); MELOXICAM (MELOXICAM),UNKNOWN; RANITIDINE (RANITIDINE),UNKNOWN; CORTISONE (CON.)
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 62