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

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Bacterial Infection (1735); Fever (1858); Chills (2191); Arthralgia (2355); Joint Swelling (2356)

Event Date 11/01/2017

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 16-feb-2018 from patient.This case concerns a (b)(6) year female patient who received treatment with synvisc one injection and after unknown latency had fluid showed infection, experienced fever, experienced chills and drained 8 syringes of fluid out of the knee.Patient had surgery in september and that she just had her right knee injected for the first time with synvisc-one.No past drug, concomitant medication and concurrent condition was provided.On an unknown date in 2017, the patient received treatment with intra- articular synvisc one injection, 1 df, once (batch/lot number and expiration date: not provided) for osteoarthritis right knee.On an unknown date in 2017, after unknown latency, the injection went fine and that it wasn't until later that night she experienced fever and chills and her knee was swelling.Patient called her md the next day but he wasn't available and so it wasn't until the following day or the second day after the injection that she saw her md.On an unknown date in 2017, after unknown latency, the md drained 8 syringes of fluid out of the knee and sent one off to have it tested for infection.A week later, it did come back and the final test they ran when they tested, it showed infection, so he told her to come back in and he drew two more vials and sent them off since it had swelled up again.Patient was sent off again the second time, it came back with no infection.Patient did take an antibiotic but she can't remember the name of the antibiotic.Patient denied engaging in any activities such as jogging or tennis soon after she received the injection.She still had issues with her knee "with pain and all".Patient also denied having any prosthetic device.Her overall health before receiving the synvisc one was good.There were not any other medications injected into her knee at the same time as the synvisc one that she was aware of and she was watching.Patient had a follow up appointment with doctor in two weeks.Corrective treatment: antibiotics for fluid showed infection; not reported for rest of the events outcome: recovered/ resolved for fluid showed infection; unknown for rest of the events seriousness criteria: important medical event for fluid showed infection a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Pharmacovigilance comment: sanofi company comment dated 26-feb-2018: this case concerns a female patient who has received treatment with synvisc one for osteoarthritis right knee and his fluid showed infection.The event onset date and treatment dates for device are not available and therefore an exact temporal relationship cannot be established.However, the event occurred in closed proximity to the site of injection and complete causal relationship cannot be denied.

Event Description

This unsolicited case from united states was received on 16-feb-2018 from patient.This case concerns a 64 year female patient who received treatment with synvisc one injection and after unknown latency had fluid showed infection, experienced issues with her knee "with pain and all", knee was swelling and drained 8 syringes of fluid out of the knee.Patient had surgery in (b)(6) and that she just had her right knee injected for the first time with synvisc-one.No past drug, concomitant medication and concurrent condition was provided.On an unknown date in 2017, the patient received treatment with intra- articular synvisc one injection, 1 df, once (batch/lot number and expiration date: not provided) for osteoarthritis right knee.On an unknown date in 2017, after unknown latency, the injection went fine and that it wasn't until later that night she experienced fever and chills and her knee was swelling.Patient called her md the next day but he wasn't available and so it wasn't until the following day or the second day after the injection that she saw her md.On an unknown date in 2017, after unknown latency, the md drained 8 syringes of fluid out of the knee and sent one off to have it tested for infection.A week later it did come back and the final test they ran when they tested it showed infection so he told her to come back in and he drew two more vials and sent them off since it had swelled up again.Patient was sent off again the second time it came back with no infection.Patient did take an antibiotic but she can't remember the name of the antibiotic.Patient denied engaging in any activities such as jogging or tennis soon after she received the injection.She still had issues with her knee "with pain and all".Patient also denied having any prosthetic device.Her overall health before receiving the synvisc one was good.There were not any other medications injected into her knee at the same time as the synvisc one that she was aware of and she was watching.Patient had a follow up appointment with doctor in two weeks.Corrective treatment: antibiotics for fluid showed infection; not reported for rest of the events outcome: recovered/ resolved for fluid showed infection; not recovered for rest of the events seriousness criteria: important medical event for fluid showed infection 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 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 adverse events to determine if a capa was required.Additional information was received on 28-feb-2018.Global ptc number and ptc results added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated 28-feb-2018: this case concerns a female patient who has received treatment with synvisc one for osteoarthritis and developed joint infection afterwards.The event onset date and treatment dates for device are not available and therefore an exact temporal relationship cannot be established.However, the event occurred in close proximity to the site of injection and complete causal relationship cannot be denied.

Event Description

Device malfunction [device malfunction] large joint effusion/effusion right knee recurrent [effusion (r) knee] chills [chills] has discomfort while getting up from seated position [general discomfort] fell [fall] fever/fever to 99 [fever] issues with her knee "with pain and all"/right knee pain increasing [knee pain] knee was swelling [swelling of r knee] ([condition aggravated]) some warmth in knee [injection site joint warmth] case narrative: this unsolicited legal case from united states was received on (b)(6) 2018 from patient.This case concerns a 64 year female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) injection and had issues with her knee "with pain and all"/right knee pain increasing (latency: 2 days), knee was swelling, chills, fever/fever to 99 (latency: 0 day) and large joint effusion/effusion right knee recurrent, some warmth in knee, fell, has discomfort while getting up from seated position (latency: unknown).A device malfunction was noted in the reported batch number.Patient had surgery in september and that she just had her right knee injected for the first time with synvisc-one, arthroscopy knee w/menisectomy (right) with debridement/shaving of articular cartilage (chondroplasty), same or separate compartments, excision of right knee joint, percutaneous endoscopic approach on (b)(6) 2017 and hand surgery right.The patient's family history included diabetes mellitus, hypertension and malignant lymphoma with mother.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient had ongoing arteriosclerosis, cellulitis, knee pain, morbid obesity.Patient wears glasses, is alcohol user (beer, daily) since (b)(6)-2017 and was a non-smoker.She denies an allergy history to avian proteins, feathers, or egg products.On (b)(6) 2017, the patient received treatment with intra- articular hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once (lot number: 7rsl021; expiration date: may-2020) for osteoarthritis right knee.It was reported that the injection went fine and that it wasn't until later that night she experienced fever and chills and her knee was swelling (latency: 0 day).On (b)(6) 2017, patient had fever to 99.Patient called her md the next day but he wasn't available and so it wasn't until the following day or the second day after the injection that she saw her md.On an unknown date in nov-2017, after unknown latency, patient had large right knee effusion.On (b)(6) 2017, patient informed of increasing pain swelling of right knee.It was reported that the md carried aspiration of knee and drained 8 syringes (20 cc) of yellow fluid out and sent one off to have it tested for infection.Patient also took dexamethasone and lidocaine injections for the effusion.A week later the test results came back and the final test they ran when they tested it showed gram negative rod proteus mirabilis so he told her to come back in and he drew two more vials and sent them off since it had swelled up again.On (b)(6) 2017, doctor noted that patient worked in agriculture field and she was currently in crawfish season.Patient denied any fever and chills or nay other complaints so they discussed the possibility of the broth to be in contaminate given its negative culture as well as negative gram stain and white blood count being around 20,000.Patient was sent off again the second time it came back with no infection.Patient did take an antibiotic but she can't remember the name of the antibiotic.On (b)(6) 2017, patent had repeat exam and the doctor suspect ted that the positive broth culture was a contaminate as nothing was growing out on culture now and repeat culture showed no bacterial growth.Patient stated she was feeling better and was working in a pond.Physical examination showed no signs of dvt or infection, no effusion, calf tenderness and normal gait.Patient denied engaging in any activities such as jogging or tennis soon after she received the injection.She still had issues with her knee "with pain and all".Patient also denied having any prosthetic device.Her overall health before receiving the hylan g-f 20, sodium hyaluronate was good.There were not any other medications injected into her knee at the same time as the synvisc one that she was aware of and she was watching.Patient had a follow up appointment with doctor in two weeks.Patient had occasionally some warmth in the knee (onset date, latency: unknown).On an unknown date in 208, (few weeks before (b)(6) 2018), after unknown latency, patient fell and had discomfort while getting up from a seated position after she had to change positions at work.On (b)(6) 2018, patient had knee warmth and mild effusion.Relevant laboratory test results included: aspiration joint - on (b)(6) 2017: 20 cc yellow fluid unk culture - on (b)(6) 2017: proteus mirabilis unk [time: 08:20]; on (b)(6) 2017: no growth unk [time: 09:00 at 5 days]; on (b)(6) 2018: no growth unk [time: 16:30 at 5 days] gram stain - on (b)(6) 2017: few wbcs no bacteria seen unk [time: 08:20]; on (b)(6) 2017: rare wbcs, no bacteria seen unk [time: 09:00]; on (b)(6)-2018: few wbcs no bacteria seen unk [time: 16:30] synovial fluid analysis - on (b)(6) -2017: no growth of anaerobes unk [time: 08:20] then no crystals seen under polarized light unk [time: 12:51]; on (b)(6) 2017: no growth of anaerobes unk [time: 09:00] then no polarizable crystals identified unk [time: 09:00]; on (b)(6)2018: no growth of anaerobes unk [time: 16:30] then no polarizable crystals identified unk [time: 16:30] corrective treatment: drained 8 syringes of fluid out of the knee, dexamethasone, lidocaine for large joint effusion/effusion right knee recurrent; not reported for rest outcome: recovered/ resolved for chills, fever/fever to 99; not recovered for large joint effusion/effusion right knee recurrent; unknown for rest seriousness criteria: intervention required for large joint effusion/effusion right knee recurrent and device malfunction a pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52723 an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation is completed, corrective and preventive actions would be implemented.Additional information was received on (b)(6) 2018.Global ptc number and ptc results added.Text was amended accordingly.Follow up was received on (b)(6) 2018.No new information was received.Additional information was received on (b)(6)-2018 from lawyer.Medical history was updated.Lot number, therapy date and dosing details of hylan g-f 20, sodium hyaluronate were added.Event of device malfunction, fell, has discomfort while getting up from seated position and some warmth in knee was added with details.Event of fluid showed infection was deleted.Verbatim of drained 8 syringes of fluid out of the knee was updated to event large joint effusion/effusion right knee recurrent and its corrective was added.Verbatim of event issues with her knee "with pain and all" was updated to issues with her knee "with pain and all"/right knee pain increasing.Seriousness criteria was updated.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7299564
• MDR Text Key: 101061220
• Report Number: 2246315-2018-00353
• 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: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 77