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

Lot Number DRSL035C

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

Patient Problems Unspecified Infection (1930); Skin Infection (4544)

Event Date 02/01/2024

Event Type  Injury  

Event Description

Experienced an infection after the injection/reaction after an injection [injection site joint infection].Case narrative: initial information received from united states on 13-feb-2024 regarding an unsolicited valid serious case received from a other health professional.This case involves a 77 years old male patient who experienced an infection after the injection/reaction after an injection while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient had received synvisc-one multiple times previously.On (b)(6) 2024, the patient started taking hylan g-f 20, sodium hyaluronate injection in left knee of strength 48 mg/6ml 1x (once) (lot - drsl035c) for osteoarthritis (unknown expiry date, dose, route).She states that she just has the lot number to provide but not the expiration date as the box was discarded the caller states that she was a clinical supervisor who was calling about a patient who had a reaction after an injection.She wants to know how we handle this.She states that the box that it came in has been discarded as well as the synvisc-one syringe itself so the udi(unique device identifier) number was not asked for.She states that she just has the lot number to provide but not the expiration date.She states that the patient experienced an infection after the injection (injection site joint infection) (onset: (b)(6) 2024; few days: latency; seriousness criteria: medically significant) that was done on (b)(6) 2024.She was requesting a replacement or a refund for the synvisc-one syringe.Action taken was not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was unknown for the event.

Manufacturer Narrative

Sanofi company comment dated 16-feb-2024: this case involves 77 years old male patient who experienced an infection after the injection/reaction after an injection while being treated with hylan g-f 20, sodium hyaluronate.This case currently lack sufficient and consistent information to permit a proper assessment.A better description including chronology, as well as information on family history if any and relevant medical history of the patient, as well as concurrent conditions are currently missing.The case will be reassessed based on follow-up information that will be received.

Event Description

Experienced an infection after the injection/reaction after an injection [injection site joint infection].Case narrative: initial information received from united states on 13-feb-2024 regarding an unsolicited valid serious case received from a other health professional.This case involves a 77 years old male patient who experienced an infection after the injection/reaction after an injection while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient had received synvisc-one multiple times previously.On (b)(6) 2024, the patient received hylan g-f 20, sodium hyaluronate injection in left knee of strength 48 mg/6ml 1x (once) (with unknown dose and route; lot number: drsl035c and expiry date: 30-jun-2026) for osteoarthritis.It was not the first time that he received the synvisc-one injection.The caller states that she was a clinical supervisor who was calling about a patient who had a reaction after an injection.She wants to know how we handle this.She states that the box that it came in has been discarded as well as the synvisc-one syringe itself so the udi (unique device identifier) number was not asked for.She states that she just has the lot number to provide but not the expiration date.She states that the patient experienced an infection after the injection (injection site joint infection) (onset: feb-2024; latency: unknown; seriousness criteria: medically significant).She was requesting a replacement or a refund for the synvisc-one syringe.Action taken was not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was unknown for the event.A product technical complaint (ptc) was initiated on 13-feb-2024 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: drsl035c and expiry date: 30-jun-2026) with global ptc number (gptc): (b)(4).The sample was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii - (dp 14feb24).The production and quality control documentation for lot # drsl035c expiration date (2026-06) was manufactured on 17jul23 packaged (b)(4) singles were 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 # drsl035c no capa (corrective action and preventive action) is required.As of 14feb24 there is 1 complaint on file for lot# drsl035 and all related sublots.1 complaint is on file for lot# drsl035c: (1) adverse event report.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 22-feb-2024 and the summarized conclusion was 'no assessment possible.' additional information was received on 13-feb-2024 from quality department: ptc details with global ptc number and suspect expiry date added.Text was amended accordingly.Additional information was received on 22-feb-2024 from quality department: investigation summary was received added for gptc number 100400928.Text was amended accordingly.

Event Description

Experienced an infection after the injection/reaction after an injection [injection site joint infection].Case narrative: initial information received from united states on 13-feb-2024 regarding an unsolicited valid serious case received from a other health professional.This case involves a 77 years old male patient who experienced an infection after the injection/reaction after an injection while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient had received synvisc-one multiple times previously on (b)(6) 2024, the patient started taking hylan g-f 20, sodium hyaluronate injection in left knee of strength 48 mg/6ml 1x (once) (with unknown dose and route; lot number: drsl035c and expiry date: 30-jun-2026) for osteoarthritis.The caller states that she was a clinical supervisor who was calling about a patient who had a reaction after an injection.She wants to know how we handle this.She states that the box that it came in has been discarded as well as the synvisc-one syringe itself so the udi(unique device identifier) number was not asked for.She states that she just has the lot number to provide but not the expiration date.She states that the patient experienced an infection after the injection (injection site joint infection) (onset: on (b)(6) 2024; few days: latency; seriousness criteria: medically significant) that was done on (b)(6) 2024.She was requesting a replacement or a refund for the synvisc-one syringe.Action taken was not applicable.It was not reported if the patient received a corrective treatment for the event at time of reporting, the outcome was unknown for the event a product technical complaint (ptc) was initiated on 13-feb-2024 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: drsl035c and expiry date: 30-jun-2026) with global ptc number: (b)(4).The sample was not available and ptc was set in process.Additional information was received on 13-feb-2024 from quality department: ptc details with global ptc number and suspect expiry date added.Text was amended accordingly.

Event Description

An infection after the injection/immediate infection/left knee infection with positive blood cultures growing methicillin sensitive staph cultures/remain positive, as well for methicillin-sensitive staphylococcus aureus [arthritis bacterial] ([injection site joint pain], [injection site joint swelling], [injection site joint effusion], [injection site joint warmth], [elevated sedimentation rate], [synovial fluid analysis abnormal], [wbc increased], [c-reactive protein increased], [blood culture positive for staphylococcus]) pain in both legs [pains in legs] weakness in both legs [lower extremities weakness of] some swelling in the left leg/left leg had some just generalized swelling [unilateral leg swelling] knee was aspirated [aspiration of joint].Case narrative: initial information was received on 13-feb-2024 regarding an unsolicited valid serious case received from other health professional.This case involves 77 years old male patient who had an infection after the injection/immediate infection/left knee infection with positive blood cultures growing methicillin sensitive staph (staphylococcus) cultures/remain positive, as well for methicillin-sensitive staphylococcus aureus, pain in both legs, some swelling in the left leg/left leg had some just generalized swelling, weakness in both legs and knee was aspirated while being treated with hylan g-f 20, sodium hyaluronate [synvisc one] the patient's past medical history included recent cervical spine surgery, c1-c4 (cervical) level spine fusion, approximately one month ago ((b)(6) 2024), status post cervical fusion approximately one month ago, ascending aortic aneurysm and carotid artery disease.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing bilateral knee djd (degenerative joint disease), advanced with recent cervical radiculopathy.Patient had no known drug allergies.Patient denied tobacco or alcohol use.Patient had gross degenerative changes in his knee.Patient had received synvisc-one multiple times previously and routinely does these every 3 to 6 months.On (b)(6) 2024, the patient received hylan g-f 20, sodium hyaluronate injection in left knee (strength: 48 mg/6ml) at a dose of 6ml once via route intra-articular in the office for osteoarthritis.It was not the first time that he received the synvisc-one injection.Upon follow-up, it was reported that patient started having pain in both legs (pain in extremity) (lot number: drsl035c and expiry date: 30-jun-2026) over the weekend (onset date: (b)(6) 2024, latency: few days), with some swelling in the left leg (peripheral swelling) (onset date: (b)(6) 2024, latency: few days) (lot number: drsl035c and expiry date: 30-jun-2026).He was having some swelling (injection site joint swelling) and pain in the knee (injection site joint pain) the day after (on (b)(6) 2024, latency: 1 day) (lot number: drsl035c and expiry date: 30-jun-2026) and presented to hospital with weakness in both legs (muscular weakness) (onset date: (b)(6)2024, latency: few days) (lot number: drsl035c and expiry date: 30-jun-2026) and was admitted on (b)(6) 2024.He said he had not had any fevers or chills.He was afebrile.His vital signs were stable.His wbc was 9.9, hemoglobin 11.0, platelets 205.He was evaluated.Important in his history was that he had a recent spine surgery and prior to the spine surgery, he had complained of weakness.That was one of his main complaints that he was back in the hospital for weakness and some swelling and pain in his left knee.He denied any fevers or chills, and he was afebrile at the time.Wbc (white blood cell) was in the 12s as well (white blood cell count increased) (onset date: (b)(6) 2024, latency: 2 days) (lot number: drsl035c and expiry date: 30-jun-2026).The orthopedic doctor evaluated his knee.He had some effusion in his knee (injection site joint effusion) (onset date: (b)(6) 2024, latency: few days) (lot number: drsl035c and expiry date: 30-jun-2026).There were no obvious open wounds or drainage.The doctor offered him the ability to aspirate his knee at that time, and patient did not want to do that.He was concerned that if doctor did, he/she would aspirate the medication that was in his knee.He was placed on steroids.He continued to improve over the course of a couple days.The reporter who was a clinical supervisor reported about the patient who had a reaction after an injection.She stated that the patient experienced an infection after the injection (arthritis bacterial) (onset: (b)(6) 2024; latency: 2 days) (lot number: drsl035c and expiry date: 30-jun-2026).She was requesting a replacement or a refund for the synvisc-one syringe.The orthopedic doctor was called back by the primary care physician on (b)(6)2024, morning, patient was still complaining of his left knee.At that point in time, orthopedic doctor's nurse practitioner was sent to evaluate the patient.The wbc had elevated to 13 (white blood cell count increased).He had an elevated sedimentation rate (red blood cell sedimentation rate increased) (onset date: (b)(6) 2024, latency: 7 days) (lot number: drsl035c and expiry date: 30-jun-2026).The patient's knee was evaluated.He had some mild warmth in his knee (injection site joint warmth) (onset date: (b)(6) 2024, latency: few days) (lot number: drsl035c and expiry date: 30-jun-2026).The fusion had gotten somewhat better from the time patient was examined earlier.The nurse aspirated the knee (aspiration joint) (onset date: (b)(6) 2024, latency: 7 days) (lot number: drsl035c and expiry date: 30-jun-2026) and there was some dark discharge from the aspiration (synovial fluid analysis abnormal) (onset date: (b)(6) 2024, latency: 7 days) (lot number: drsl035c and expiry date: 30-jun-2026).At that point in time, doctor felt it appropriate to proceed with urgent irrigation and debridement of his knee and then, he was scheduled to do that.On (b)(6) 2024, the patient was presented to the operating room and underwent general endotracheal anesthesia.Left lower extremity was placed in johnson leg holder, sterilely prepped and draped.An anterolateral portal was established.Upon entry into the joint, he had brown, milky fluid that was removed, probably at least 20 to 30 ml, that was sent for cultures.An anterolateral portal was established.The patellofemoral joint and pretty much the whole joint had gross tricompartmental arthritis that was preexisting.That is what patient was being treated for.Sweeping the medial gutter, there was very little left in his medial meniscus, but gross degenerative changes of his knee medial.Acl (anterior cruciate ligament) and pcl (posterior cruciate ligament) were intact, though frayed.Lateral joint line had a tear.Lateral meniscus appeared to be intact.Doctor debrided back to a stable surface with a shaver, and gross degenerative changes were noted in that compartment.Doctor went back into the suprapatellar pouch and cleaned up the suprapatellar pouch.6 liters of antibiotic solution was run through the knee.At the end, just normal fluid was coming out of his joint.A drain was put in the anteromediel portal and did a purse stitch on that and closed the other one with a normal mattress suture in the anterolateral portal.Sterile dressings were applied.The patient tolerated the procedure well.Ebl (estimated blood loss) was minimal.Specimens were just a culture.There were no obvious complications.Tourniquet was never inflated.On (b)(6) 2024, patient was seen, still with similar complaints of knee, some occasional pain.Denied any fever or chills.On physical examination, the left leg had some just generalized swelling (peripheral swelling).His drain was still putting out some drainage.It was cloudy.He was weak in the left leg, but he was able to dorsiflex and plantarflex approximately 4+/5.He had 1+ dorsalis pedis pulse.Sensation was just generalized diminished in both legs ½.As per lab data on (b)(6) 2024, patient wbc was trending back up.It went from 17 over the weekend up to 19.4 on (b)(6) 2024 (white blood cell count increased).His c-reactive protein was elevated, it went from 23 to 25 as well (c-reactive protein increased) (onset date: (b)(6) 2024, latency: few days) (lot number: drsl035c and expiry date: 30-jun-2026).He had also been having positive blood culture (arthritis bacterial) as well.The examining doctor talked to patient's primary care and they both felt it was probably best to urgently and emergently proceed to taking patient back to operating room for another washout of his left knee.His initial blood cultures were growing methicillin sensitive staph cultures (staphylococcal infection) (onset date: (b)(6) 2024, latency: few days) (lot number: drsl035c and expiry date: 30-jun-2026).New cultures were taken on (b)(6) 2024.There was a concern that patient might become septic at some point in time, so doctors were moving emergently and urgently to wash out his knee again on (b)(6) 2024.On (b)(6)2024, the patient was presented to the operating room and underwent general endotracheal anesthesia.The left lower extremity was sterilely prepped and draped, put in a johnson leg holder.Read our timeout, established.Doctor went through the previous anterolateral portal and anteromedial portal.Upon entry into the patellofemoral joint, it was grossly arthritic.He had tricompartmental arthritis throughout, advanced.Doctor did not see any signs of gross infection at this point in time.At the beginning of the case, they were able to get fluid out, probably about 10 to 15 ml of fluid.This time it was more of a bloody discharge with some small pieces of debris and that was sent for cultures.They swung down to the medial portal, evaluated that side, again gross degenerative changes.They went to the intercondylar notch.They went to the lateral joint line and back to the suprapatellar pouch.They did some light debridement of the synovium throughout, but there was really no evidence of any gross infection at this point in time.They irrigated with at least 6 liters of antibiotic solution, and once they were done with irrigation and debridement, they discontinued the arthroscopy, put a drain in through the anteromedial portal and closed the incision with interrupted suture.Sterile dressings were applied.The patient tolerated the procedure well.The estimated blood loss was minimal.No complications.Doctor took specimen cultures and those were sent off.The patient would be awakened, taken to recovery room.On (b)(6) 2024, patient was postop day 3 from left knee irrigation and debridement.Over the last 12 hours or so, an increased swelling of his knee was noted and he had a pustule erupt with pus from his cervical posterior neck wound.At this point, the patient's left knee condition continued to improve.On physical examination of his knee on (b)(6) 2024, he had no erythema.Drain was putting out only about 15ml, it was removed and dressed.His range of motion was about 30 to about 35 degrees, which was pretty close to his prehospitalization range of motion.He was neurovascularly intact throughout the left lower extremity with 1+ dorsalis pulse.Motor and sensory were grossly intact throughout the left lower extremity.In the bottom of his neck wound, he had an opening probably about 3 to 4 nun(unknown units) with some clear drainage at this point in time.The patient's blood cultures remain positive, as well for methicillin-sensitive staphylococcus aureus (staphylococcus test positive).It was pretty evident at this point: in time that the knee sounded like it was no longer involved in the process.It continued to look improved.The last washout, it looked fairly benign.The doctor did not felt any gross evidence of infection.The drain was pulled out on (b)(6) 2024, because there was hardly any drainage left in the knee and there was no redness or any obvious sip's of infection of his left knee at this point in time.The patient was still being seen by doctor of infectious diseases.The nurse told doctor that they were planning to do possibly an interventional aspiration of the cervical neck wound at this point in time.The doctor felt that likely, unfortunately, the neck wound was probably responsible for the elevated wbc (white blood cell count increased).From an orthopedic point of view, at this point in time, doctor do not think any further intervention was necessary for his left knee.Doctor would continue to monitor his progress.The patient was weightbearing as tolerated on the left lower extremity.Encourage range of motion of the left knee.The patient would remain on antibiotics and those decisions would be made by doctor of infectious diseases.Relevant laboratory test results included: blood culture - on (b)(6) 2024: [blood cultures were growing methicillin sensitive staph cultures]; in (b)(6) 2024: [positive]; in (b)(6) 2024: [blood cultures remain positive, as well for methicillin-sensitive staphylococcus aureus.] c-reactive protein - on (b)(6) 2024 23 haemoglobin - on (b)(6) 2024: 11.0 [units not provided]; on (b)(6) 2024: 10.8 [units not provided] platelet count - on (b)(6) 2024: 205; on (b)(6)2024: 368 [units not provided] red blood cell sedimentation rate - (b)(6) 2024: [elevated] synovial fluid analysis - on (b)(6) 2024: [aspirated the knee and there was some dark discharge from the aspiration/brown, milky fluid that was removed, probably at least 20 to 30 ml]; on (b)(6) 2024: [cloudy, more of a bloody discharge with some small pieces of debris] white blood cell count - on (b)(6) 2024: 9.9 [units not reported]; on (b)(6) 2024: 19.4 [wbc was trending back up]; on (b)(6) 2024: 17; in (b)(6) 2024: wbc was in the 12s[units not provided]; in (b)(6) 2024: 13 [elevated]; in (b)(6) 2024: [climbing to 19]; in (b)(6) 2024: 17 [over the weekend] action taken was not applicable for all events.Corrective treatment: intravenous antibiotics (unspecified), steroids(unspecified), left knee arthroscopic irrigation and debridement with partial lateral meniscectomy with application of drain twice for arthritis bacterial.At time of reporting, the outcome was recovering for arthritis bacterial, pain in extremity, peripheral swelling; unknown for aspiration joint.Seriousness criteria: hospitalization, medically significant and intervention required for arthritis bacterial, hospitalization for pain in extremity, peripheral swelling,muscular weakness; hospitalization and medically significant for aspiration joint.A product technical complaint (ptc) was initiated on 13-feb-2024 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: drsl035c and expiry date: 30-jun-2026) with global ptc number (gptc): (b)(4).The sample was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii - (dp 14feb24).The production and quality control documentation for lot # drsl035c expiration date (2026-06) was manufactured on 17jul23 packaged 8791 singles were 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 # drsl035c no capa (corrective action and preventive action) is required.As of 14feb24 there is 1 complaint on file for lot# drsl035 and all related sublots.1 complaint is on file for lot# drsl035c: (1) adverse event report.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 22-feb-2024 and the summarized conclusion was 'no assessment possible.' additional information was received on 13-feb-2024 from quality department: ptc details with global ptc number and suspect expiry date added.Text was amended accordingly.Additional information was received on 22-feb-2024 from quality department: investigation summary was received added for gptc number (b)(4).Text was amended accordingly.Additional information was received on 19-apr-2024 from other health professional: event of injection site joint infection was updated to arthritis bacterial.New events added: pain in extremity, peripheral swelling, and aspiration joint.Medical history and concurrent conditions were added.Suspect dose and route were added.Relevant lab data was added.Clinical course was updated, and text was amended.Additional information was received on 28-may-2024 from other health professional: new event (muscular weakness) added.Linking were updated from methicillin-sensitive staphylococcus aureus infection to staphylococcus test positive and synovial fluid colour to synovial fluid analysis abnormal.Clinical course was updated, and text was amended.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 18721089
• MDR Text Key: 335581349
• Report Number: 2246315-2024-00011
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2024

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 Lot Number: DRSL035C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/20/2024; 02/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Sex: Male
• Patient Weight: 77 KG