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

Lot Number 6RSP001

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

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

Event Date 08/02/2016

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 08-sep-2016 from a physician.This case concerns a male patient (age not provided) who received treatment with synvisc injection and later after unknown latency experienced pseudoseptic reaction.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.The patient had no known avian allergy.On an unknown date, the patient initiated treatment with intra-articular synvisc injection (dose, frequency, indication, batch/lot and expiration date not provided).On an unspecified date, after unknown latency, patient's knee was very swollen and hot after receiving the second injection.Patient never had pain like this before.The patient was sent to the emergency room (er).Patient's knee was washed out and he stayed in the hospital for four days.Patient had iv antibiotics.The fluid was pulled off and cultured, but it was not an infection.It was believed to be a pseudoseptic reaction because it was negative for being an infection.Patient's white blood cell (wbc) was around 60,000.Action taken: unknown.Corrective treatment: knee washed out and iv antibiotics.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: hospitalization.

Event Description

This unsolicited case from united states was received on 08-sep-2016 from a physician.This case concerns a male patient (age not provided) who received treatment with synvisc injection and later after unknown latency experienced pseudoseptic reaction.No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.The patient had no known avian allergy.On an unknown date, the patient initiated treatment with intra- articular synvisc injection (dose, frequency, indication, batch/lot and expiration date not provided).On an unspecified date, after unknown latency, patient's knee was very swollen and hot after receiving the second injection.Patient never had pain like this before.The patient was sent to the emergency room (er).Patient's knee was washed out and he stayed in the hospital for four days.Patient had iv antibiotics.The fluid was pulled off and cultured, but it was not an infection.It was believed to be a pseudoseptic reaction because it was negative for being an infection.Patient's white blood cell (wbc) was around 60,000.Action taken: unknown.Corrective treatment: knee washed out and iv antibiotics.Outcome: unknown.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 was 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 will continue to monitor adverse events to determine if a capa is required.Seriousness criteria: hospitalization.Additional information was received on 13-sep-2016.Global ptc number and results were added and text was amended accordingly.

Event Description

This unsolicited case from united states was received on 08-sep-2016 from a physician.This case concerns a (b)(6) male patient who received treatment with synvisc injection and later after 7 days experienced septic knee.The medical history was significant for degenerative joint disease (djd) of both knees, gastroesophageal reflux disease (gerd), sleep apnea and hypertension.The concomitant medication was meloxicam and testosterone.No relevant past drugs and concurrent conditions were reported.The patient had no known avian allergy.On (b)(6) 2016, the patient initiated treatment with intra- articular synvisc injection at a dose of 4 ml weekly (batch/lot number: 6rsp001; expiration date not provided) into unspecified location for degenerative joint disease.On (b)(6) 2016, at 09:15, the patient received the second synvisc injection.The same day, at approximately 06:00 p.M., 7 days after the first injection, the patient experienced swelling and pain of the right knee.It was reported that the patient's knee was very swollen and hot after receiving the second injection.Patient never had pain like this before.The patient had a septic knee.The patient was sent to the emergency room (er).Patient's knee was washed out and he stayed in the hospital for four days.Patient had iv antibiotics.The fluid was pulled off and cultured, but it was not an infection.It was believed to be a pseudoseptic reaction because it was negative for being an infection.Patient's white blood cell (wbc) was around 60,000.On (b)(6) 2016, the patient was seen in office and the doctor ordered lab work and referred the patient to another doctor.The same day, the gram stain was 4+, aerobic culture showed no growth in 5 days and body fluid cell count of right knee aspirate was turbid with red blood cell (rbc) count of 10300 and wbc count of 63980.On an unknown date in (b)(6) 2016, the pre-operative diagnosis was arthritis, septic knee; g4 cm mfc, mtp; medical meniscal tear and loose body right knee.The doctor performed arthroscopy with irrigation and debridement of the right septic knee.Partial medical meniscectomy and loose body removal right knee were also performed.The tissue from right knee joint was removed and the tests performed were body fluid crystal, surgical pathological exam.From the wound of right knee, anaerobic culture and wound culture was performed.The post-operative diagnosis was the same as pre-operative diagnosis.The patient was sent to post anesthesia care unit (pacu) in stable condition.Action taken: permanently discontinued.Corrective treatment: knee washed out; iv antibiotics; arthroscopy, irrigation and debridement.Outcome: not recovered.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 was 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 will continue to monitor adverse events to determine if a capa is required.Reporter causality: suspected for effusion.Seriousness criteria: hospitalization and required intervention.Additional information was received on 13-sep-2016.Global ptc number and results were added and text was amended accordingly.Additional information was received on 21-feb-2017 from a nurse.The age of the patient, medical history and concomitant medication were added.The event was updated from pseudoseptic reaction to septic knee with details.The suspect drug start date, dose, frequency, lot number, indication and stop date were added.The event start date and hospitalization date were added.The relevant lab data was added.The action taken was updated from unknown to permanently discontinued.Additional corrective treatment was added.The outcome was updated from unknown to not recovered.The seriousness criterion of required intervention was added.The reporter causality was added.Clinical course updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment dated 21-feb-2017: this case concerns a male patient who received treatment with synvisc and the same day after second injection experienced joint swelling and pain which was further diagnosed as arthritis infective.On the basis of significant temporal relationship and site of reaction the causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding the conditions in which synvisc was injected, medical history, past drugs and any relevant lab data complete medical assessment of the case is difficult.

Event Description

This unsolicited case from united states was received on 08-sep-2016 from a physician.This case concerns a (b)(6) male patient who received treatment with synvisc injection and later after 7 days experienced septic knee.The medical history was significant for degenerative joint disease (djd) of both knees, gastroesophageal reflux disease (gerd), sleep apnea and hypertension.The concomitant medication was meloxicam and testosterone.No relevant past drugs and concurrent conditions were reported.The patient had no known avian allergy.On (b)(6) 2016, the patient initiated treatment with intra- articular synvisc injection at a dose of 4 ml weekly (batch/lot number: 6rsp001; expiration date: feb-2019) into unspecified location for degenerative joint disease.On (b)(6) 2016, at 09:15, the patient received the second synvisc injection.The same day, at approximately 06:00 p.M., 7 days after the first injection, the patient experienced swelling and pain of the right knee.It was reported that the patient's knee was very swollen and hot after receiving the second injection.Patient never had pain like this before.The patient had a septic knee.The patient was sent to the emergency room (er).Patient's knee was washed out and he stayed in the hospital for four days.Patient had iv antibiotics.The fluid was pulled off and cultured, but it was not an infection.It was believed to be a pseudoseptic reaction because it was negative for being an infection.Patient's white blood cell (wbc) was around 60,000.On (b)(6) 2016, the patient was seen in office and the doctor ordered lab work and referred the patient to another doctor.The same day, the gram stain was 4+, aerobic culture showed no growth in 5 days and body fluid cell count of right knee aspirate was turbid with red blood cell (rbc) count of 10300 and wbc count of 63980.On an unknown date in (b)(6) 2016, the pre-operative diagnosis was arthritis, septic knee; g4 cm mfc, mtp; medical meniscal tear and loose body right knee.The doctor performed arthroscopy with irrigation and debridement of the right septic knee.Partial medical meniscectomy and loose body removal right knee were also performed.The tissue from right knee joint was removed and the tests performed were body fluid crystal, surgical pathological exam.From the wound of right knee, anaerobic culture and wound culture was performed.The post-operative diagnosis was the same as pre-operative diagnosis.The patient was sent to post anesthesia care unit (pacu) in stable condition.Action taken: permanently discontinued.Corrective treatment: knee washed out; iv antibiotics; arthroscopy, irrigation and debridement.Outcome: not recovered.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).The production and quality control documentation for lot # 6rsp001 expiration date (02/2019) 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 # 6rsp001 no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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 complaints to determine if a capa was required.Reporter causality: suspected for effusion.Seriousness criteria: hospitalization and required intervention.Additional information was received on 13-sep-2016.Global ptc number and results were added and text was amended accordingly.Additional information was received on 21-feb-2017 from a nurse.The age of the patient, medical history and concomitant medication were added.The event was updated from pseudoseptic reaction to septic knee with details.The suspect drug start date, dose, frequency, lot number, indication and stop date were added.The event start date and hospitalization date were added.The relevant lab data was added.The action taken was updated from unknown to permanently discontinued.Additional corrective treatment was added.The outcome was updated from unknown to not recovered.The seriousness criterion of required intervention was added.The reporter causality was added.Clinical course updated and text amended accordingly.Additional information was received on 27-feb-2017.The expiration date and the ptc results with lot details were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 27-feb-2017: the additional information does not alter the previous case assessment.Sanofi company comment dated 21-feb-2017: this case concerns a male patient who received treatment with synvisc and the same day after second injection experienced joint swelling and pain which was further diagnosed as arthritis infective.On the basis of significant temporal relationship and site of reaction the causal role of suspect product cannot be denied in occurrence of the event.However, due to lack of information regarding the conditions in which synvisc was injected, medical history, past drugs and any relevant lab data complete medical assessment of the case is difficult.

• Brand Name: SYNVISC
• 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: 5949318
• MDR Text Key: 54670228
• Report Number: 2246315-2016-00143
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/01/2019
• Device Lot Number: 6RSP001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• 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: 45 YR
• Patient Weight: 140