MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL001

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Joint Disorder (2373)

Event Date 08/01/2017

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 21-aug-2017 from an other non-health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and later after unknown latency developed staph infection in joint.No relevant medical history, past drug, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intraarticular bilateral synvisc one injection, once (lot number: 7rsl001; dose and expiration date: not provided) for osteoarthritis of knee.On an unspecified date in (b)(6) 2017, after unknown latency, patient developed staph infection in joint in one knee (unspecified) only.It was reported that the patient had a surgery as treatment and was in hospital.Corrective treatment: surgery.Outcome: recovering.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: hospitalization.Pharmacovigilance comment: sanofi company comment dated 29-aug-2017: this case concerns a patient who received treatment with synvisc one and later experienced joint infection.The causal role of suspect product in occurrence of the event cannot be denied on basis of site of reaction.However, due to lack of information regarding maintenance of aseptic conditions under which injection was administered and technique of injection complete medical assessment of the case is difficult.

Event Description

Based on additional information received on 12-oct- 2017, this case became medically confirmed (reported by a physician).This unsolicited case from united states was received on 21-aug-2017 from an other non-health care professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and later after unknown latency developed staph infection in joint/culture (b)(6).No relevant concurrent conditions were reported.Relevant concomitant medications includes ondansetron hydrochloride (zofran), atenolol and losartan potassium (losartan).Medical history includes colon cancer, chronic obstructive pulmonary disease (copd), hypertension (htn) and coronary artery disease (cad) and asthma.Patient had allergy to tetracycline and acetylsalicylic acid (asa) and sulfa allergy.Past medication included synvisc one ((b)(6) 2016; one injection).On (b)(6) 2017, patient received treatment with intraarticular bilateral synvisc one injection, once (lot number: 7rsl001; dose and expiration date: dec-2019) for osteoarthritis of knee.On an unspecified date in (b)(6) 2017, after unknown latency, patient developed staph infection in joint in one knee (unspecified) only.It was reported that the patient had a surgery as treatment and was in hospital.On (b)(6) 2017, the patient had increasing pain in the right knee.Patient went to emergency room (er) and was started on vancomycin hydrochloride (vanco) without culture.On (b)(6) 2017, patient had post swelling, had taken tool surgery for orthoscopic debridement and irrigation.Culture showed culture (b)(6).On the same day c & s test (urine culture and sensitivity test) was performed that showed staph aureus not (b)(6).On (b)(6) 2017, the arthroscopy was done.Corrective treatment: surgery and started on vancomycin hydrochloride.Outcome: recovering.A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).The production and quality control documentation for lot # 7rsl001 expiration date (12/2019) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl001 no capa was required.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 had not indicated any safety issue.Sanofi would continue to monitor in order to determine if a capa was required.Reporter causality: related.Seriousness criteria: hospitalization.Additional information was received on 13-sep-2017.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 12-oct-2017 from physician.This case became medically confirmed.Patient height and weight.Medical history, past drugs and concomitant medication added.Symptom of post swelling was added.Clinical course updated.Text was amended accordingly.Additional information was received on 08-nov-2017.Expiration date was added.Ptc results were updated.Text was amended accordingly.Additional information was received on 13-dec-2017 from the physician.Past medication was added.Event verbatim was updated from staph infection in joint to (b)(6).Additional symptoms of increasing pain right knee and aspiration were added.Reporter causality was added.Clinical course was updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for dated 13-dec-2017: this case concerns a patient who received treatment with synvisc one and later experienced staph infection in joint/culture (b)(6) with increasing pain right knee, swelling and later aspiration was done.The causal role of suspect product in occurrence of the event cannot be denied on basis of site of reaction.However, due to lack of information regarding maintenance of aseptic conditions under which injection was administered and technique of injection complete medical assessment of the case is difficult.

Event Description

This unsolicited case from united states was received on 21-aug-2017 from an other non-health care professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and later after unknown latency developed staph infection in joint.No relevant medical history, past drug, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intraarticular bilateral synvisc one injection, once (lot number: 7rsl001; dose and expiration date: not provided) for osteoarthritis of knee.On an unspecified date in (b)(6) 2017, after unknown latency, patient developed staph infection in joint in one knee (unspecified) only.It was reported that the patient had a surgery as treatment and was in hospital.Corrective treatment: surgery.Outcome: recovering.A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was 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 monitored 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: hospitalization.Additional information was received on 13-sep-2017.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 19-sep-2017: the follow up information does not changed the previous case assessment.This case concerns a patient who received treatment with synvisc one and later experienced joint infection.The causal role of suspect product in occurrence of the event cannot be denied on basis of site of reaction.However, due to lack of information regarding maintenance of aseptic conditions under which injection was administered and technique of injection complete medical assessment of the case is difficult.

Event Description

Based on additional information received on 12-oct- 2017, this case became medically confirmed (reported by a physician).This unsolicited case from united states was received on 21-aug-2017 from an other non-health care professional.This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and later after unknown latency developed staph infection in joint.No relevant concurrent conditions were reported.Relevant concomitant medications includes ondansetron hydrochloride (zofran), atenolol and losartan potassium (losartan).Medical history includes colon cancer, copd (chronic obstructive pulmonary disease), hypertension and coronary artery disease (cad) and asthma.Patient had allergy to tetracycline and acetylsalicylic acid (asa) and sulfa allergy.On (b)(6) 2017, patient received treatment with intraarticular bilateral synvisc one injection, once (lot number: 7rsl001; dose and expiration date: not provided) for osteoarthritis of knee.On an unspecified date in (b)(6) 2017, after unknown latency, patient developed staph infection in joint in one knee (unspecified) only.It was reported that the patient had a surgery as treatment and was in hospital.On (b)(6) 2017, patient had post swelling, had taken tool surgery for orthoscopic debridement and irrigation.On the same day c & s test (urine culture and sensitivity test) was performed that showed staph aureus not (b)(6).Corrective treatment: surgery.Outcome: recovering a pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was 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 monitored 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: hospitalization.Additional information was received on 13-sep-2017.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 12-oct-2017 from physician.This case became medically confirmed.Patient height and weight.Medical history, past drugs and concomitant medication added.Symptom of post swelling was added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for dated 12-oct-2017: the new follow-up information received does not change the previous case assessment of the case.This case concerns a patient who received treatment with synvisc one and later experienced joint infection.The causal role of suspect product in occurrence of the event cannot be denied on basis of site of reaction.However, due to lack of information regarding maintenance of aseptic conditions under which injection was administered and technique of injection complete medical assessment of the case is difficult.

Event Description

Based on additional information received on 12-oct- 2017, this case became medically confirmed (reported by a physician) this unsolicited case from united states was received on (b)(6) 2017 from an other non-health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and later after unknown latency developed staph infection in joint.No relevant concurrent conditions were reported.Relevant concomitant medications includes ondansetron hydrochloride (zofran), atenolol and losartan potassium (losartan).Medical history includes colon cancer, copd (chronic obstructive pulmonary disease), hypertension and coronary artery disease (cad) and asthma.Patient had allergy to tetracycline and acetylsalicylic acid (asa) and sulfa allergy.On (b)(6) 2017, patient received treatment with intraarticular bilateral synvisc one injection, once (lot number: 7rsl001; dose and expiration date: dec-2019) for osteoarthritis of knee.On an unspecified date in (b)(6) 2017, after unknown latency, patient developed staph infection in joint in one knee (unspecified) only.It was reported that the patient had a surgery as treatment and was in hospital.On (b)(6) 2017, patient had post swelling, had taken tool surgery for orthoscopic debridement and irrigation.On the same day c & s test (urine culture and sensitivity test) was performed that showed staph aureus not (b)(6).Corrective treatment: surgery.Outcome: recovering.A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).The production and quality control documentation for lot # 7rsl001 expiration date (12/2019) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl001 no capa was required.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 had not indicated any safety issue.Sanofi would continue to monitor in order to determine if a capa was required.Seriousness criteria: hospitalization additional information was received on 13-sep-2017.Global ptc number and ptc results were added.Text was amended accordingly.Additional information was received on 12-oct-2017 from physician.This case became medically confirmed.Patient height and weight.Medical history, past drugs and concomitant medication added.Symptom of post swelling was added.Clinical course updated.Text was amended accordingly.Additional information was received on 08-nov-2017.Expiration date was added.Ptc results were updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for dated 08-nov-2017: the new follow-up information received does not change the previous case assessment of the case.This case concerns a patient who received treatment with synvisc one and later experienced joint infection.The causal role of suspect product in occurrence of the event cannot be denied on basis of site of reaction.However, due to lack of information regarding maintenance of aseptic conditions under which injection was administered and technique of injection complete medical assessment of the case is difficult.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 6841058
• MDR Text Key: 84638161
• Report Number: 2246315-2017-00137
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/01/2019
• Device Lot Number: 7RSL001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 61