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

Lot Number 5RSK003G

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

Patient Problems Arthritis (1723); Limited Mobility Of The Implanted Joint (2671)

Event Date 11/01/2016

Event Type  Injury  

Event Description

This unsolicited case from (b)(6) was received on (b)(4) 2016 and 11-nov-2016 (both information processed together with clock start date: (b)(6) 2016) from a medical doctor.This case concerns a (b)(6) male patient who received treatment with synvisc one and 4 days later developed septic arthritis left knee and inflammatory joint right knee and after an unknown latency had decreased mobility.The medical history included arthritis.Patient had no known drug allergy.Past treatment included synvisc injection (3/7 years ago) and synvisc injection on (b)(6) 2016.Concomitant medications and concurrent conditions were not reported.On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection once (dose and indication: not provided) (batch/lot number: 5rsk003g and expiration date: sep-2018) in left knee.On (b)(6) 2016, 4 days after receiving treatment with synvisc one, the patient had a severe reaction and was admitted to the hospital.The same day, at 9:00 hours, the patient was examined and had right knee pain, noticed swelling from saturday but was worse today (5/10 pain), and took oxycodone hydrochloride (endone) last night.On examination, patient had decreased mobility (latency unknown), swollen knee cap, decreased range of motion (rom), had pulse rate: 97 and body temperature (bt): 36 (normal range (nl) and units: not provided).The same day, patient had white blood cell (wbc) count: 10400 x 10e6/l, red cell count: 1300x10e6/l.The patient had xray left knee that showed suprapatellar joint effusion, a bipartite patellar was noted, severe patellofemoral joint degenerative change and mild femorotibial joint compartment degenerative change.The same day, at 12:46 hours, 4 days after receiving treatment with synvisc one, patient had septic arthritis left knee.The patient had pain and swelling to same over past few days with decreased mobility.The patient was alert and oriented, well infused, complained of mild pain at triage.On (b)(6) 2016, patient had arthroscopic washout of the left knee (+/- debridement) and arthroscopy showed significant joint erosion, cartilage damage and synovitis.There was no infection but a large effusion that recurred after initial aspiration.Patient had flucloxacillin sodium (fluclox) in hospital and diclox on discharge for 6 weeks.The cultures performed were negative.At 9:20 hours, the c-reactive protein was high: 32 mg/l (nl: less than 5 mg/l).On (b)(6) 2016, the patient was discharged from the hospital with medications: enoxaparin sodium (clexane) injections at 40 mg subcutaneous, oral paracetamol at 1 g 4 times a day, oral ibuprofen at 400 mg thrice daily and oral diclox at 500 mg every 6 hours until follow up appointment.At discharge, patient's bt was 36, pulse rate was 81, blood pressure was 125/78, respiration rate was 16 and oxygen saturation was 97% (pain score: 3/10).It was reported that this was the most severe reaction that has ever occurred from doctor's experience in more than 20 years with the product.Doctor was bit hesitant to recommend synvisc after this experience, although it was documented in the product label.Perhaps doctor would highlight the possibility of severe side effects and let the patient decide.Corrective treatment: paracetamol, ibuprofen, enoxaparin sodium, dicloxacillin, flucloxacillin sodium for septic arthritis left knee; oxycodone hydrochloride for inflammatory joint right knee; not reported for decreased mobility.Outcome: unknown for all events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: hospitalization and required intervention for septic arthritis left knee; hospitalization for inflammatory joint right knee and decreased mobility.No further information was provided.Consent to contact for follow up was given.Pharmacovigilance comment: sanofi company comment dated 11-nov-2016: this case concerns a male patient who received treatment with synvisc one injected in left knee and was later hospitalized due to septic arthritis in left knee and right knee inflammation with underlying symptoms of knee pain, knee swelling, joint effusion and decreased mobility.On the basis of temporal gap of three days causal role of suspect product in occurrence of septic arthritis cannot be denied.Furthermore, patient experienced reaction in left knee where synvisc one injection was given establishing a possible role of suspect in occurrence of the event.In addition, septic left joint has been provided as differential diagnosis along with arthritis which is patient medical history which infers that patient might have experienced the reported symptoms due to his underlying medical condition.However, due to lack of information regarding maintenance of septic conditions while administration of synvisc one injection, sufficient medical history, concomitant conditions and past drugs precludes complete medical assessment of this case.

Event Description

This unsolicited case from (b)(6) was received on 08-nov-2016 and 11-nov-2016 (both information processed together with clock start date: (b)(6) 2016) from a medical doctor.This case concerns a (b)(6) male patient who received treatment with synvisc one and 4 days later developed septic arthritis left knee and inflammatory joint right knee and after an unknown latency had decreased mobility.The medical history included arthritis.Patient had no known drug allergy.Past treatment included synvisc injection (3/7 years ago) and synvisc injection on (b)(6) 2016.Concomitant medications and concurrent conditions were not reported.On (b)(6) 2016, the patient received treatment with intra-articular synvisc one injection once (dose and indication: not provided) (batch/lot number: 5rsk003g and expiration date: sep-2018) in left knee.On (b)(6) 2016, 4 days after receiving treatment with synvisc one, the patient had a severe reaction and was admitted to the hospital.The same day, at 9:00 hours, the patient was examined and had right knee pain, noticed swelling from saturday but was worse today (5/10 pain), and took oxycodone hydrochloride (endone) last night.On examination, patient had decreased mobility (latency unknown), swollen knee cap, decreased range of motion (rom), had pulse rate: 97 and body temperature (bt): 36 (normal range (nl) and units: not provided).The same day, patient had white blood cell (wbc) count: 10400 x 10e6/l, red cell count: 1300x10e6/l.The patient had xray left knee that showed suprapatellar joint effusion, a bipartite patellar was noted, severe patellofemoral joint degenerative change and mild femorotibial joint compartment degenerative change.The same day, at 12:46 hours, 4 days after receiving treatment with synvisc one, patient had septic arthritis left knee.The patient had pain and swelling to same over past few days with decreased mobility.The patient was alert and oriented, well infused, complained of mild pain at triage.On (b)(6) 2016, patient had arthroscopic washout of the left knee (+/- debridement) and arthroscopy showed significant joint erosion, cartilage damage and synovitis.There was no infection but a large effusion that recurred after initial aspiration.Patient had flucloxacillin sodium (fluclox) in hospital and diclox on discharge for 6 weeks.The cultures performed were negative.At 9:20 hours, the c-reactive protein was high: 32 mg/l (nl: less than 5 mg/l).On (b)(6) 2016, the patient was discharged from the hospital with medications: enoxaparin sodium (clexane) injections at 40 mg subcutaneous, oral paracetamol at 1 g 4 times a day, oral ibuprofen at 400 mg thrice daily and oral diclox at 500 mg every 6 hours until follow up appointment.At discharge, patient's bt was 36, pulse rate was 81, blood pressure was 125/78, respiration rate was 16 and oxygen saturation was 97% (pain score: 3/10).It was reported that this was the most severe reaction that has ever occurred from doctor's experience in more than 20 years with the product.Doctor was bit hesitant to recommend synvisc after this experience, although it was documented in the product label.Perhaps doctor would highlight the possibility of severe side effects and let the patient decide.Further reported, the patient was recovering from arthroscopy ((b)(6) 2016) and had not yet returned to work.Corrective treatment: paracetamol, ibuprofen, enoxaparin sodium, dicloxacillin, flucloxacillin sodium for septic arthritis left knee; oxycodone hydrochloride for inflammatory joint right knee; not reported for decreased mobility.Outcome: recovering/ resolving for the event of septic arthritis left knee; unknown for the events of decreased mobility and inflammatory joint right knee.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).The production and quality control documentation for lot #5rsk003g expiration date (09/2018) was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 5rsk003g 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.Causality assessment was certainly related with respect to suspect product (rationale of causality assessment: knee pain and effusion, day after injection).Seriousness criteria: hospitalization and required intervention for septic arthritis left knee; hospitalization for inflammatory joint right knee and decreased mobility.Follow up was received on 11-nov-2016.It was reported that synvisc one was injected via lateral patellofemoral approach with knee extended.Additional information was received on 17-nov-2016 from a doctor.The dose and indication of the suspect was added.Arthroscopy was added as an additional corrective treatment for the event of septic arthritis left knee.The outcome for the event of septic arthritis left knee was updated from unknown to recovering.Text amended accordingly.Additional information was received on 17-nov-2016.Ptc results were added and text amended accordingly.Pharmacovigilance comment: sanofi follow up company comment dated 17-nov-2016: the follow up information received does not change previous case assessment.Sanofi company comment dated 11-nov-2016: this case concerns a male patient who received treatment with synvisc one injected in left knee and was later hospitalized due to septic arthritis in left knee and right knee inflammation with underlying symptoms of knee pain, knee swelling, joint effusion and decreased mobility.On the basis of temporal gap of three days causal role of suspect product in occurrence of septic arthritis cannot be denied.Furthermore, patient experienced reaction in left knee where synvisc one injection was given establishing a possible role of suspect in occurrence of the event.In addition, septic left joint has been provided as differential diagnosis along with arthritis which is patient medical history which infers that patient might have experienced the reported symptoms due to his underlying medical condition.However, due to lack of information regarding maintenance of septic conditions while administration of synvisc one injection, sufficient medical history, concomitant conditions and past drugs precludes complete medical assessment of this case.

• Brand Name: SYNVISC ONE (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: 6105346
• MDR Text Key: 59968300
• Report Number: 2246315-2016-00171
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

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 Expiration Date: 09/01/2018
• Device Lot Number: 5RSK003G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• 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
• Treatment: SYNVISC ONE(PREV.) -START; SYNVISC ONE(PREV.)-STOP; SYNVISC(PREV.)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR