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

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 11/01/2017

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 23-jan-2018 from a patient's wife.This case concerns a (b)(6) male patient who received treatment with synvisc one injection and later after unknown latency could barely walk immediately after the injection/ very unstable/ could not move, could not put weight on it, can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen, very painful/ worst pain/ still had constant pain and had infection and also, device malfunction was identified for the reported lot number.In the past patient had the past he has received 2 synvisc one injections in his left knee, 3 synvisc-one injections in the right knee, got cortisone injections in his spine, and in his left knee that was bone on bone.No relevant medical history, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patients initiated treatment with intra- articular synvisc one injection at a dose of 10 ml syringe (lot no.: 7rsl021; expiry not provided) (frequency: not provided) for osteoarthritis and tear in the knee.Patient didn't felt as bad.He had to take care of her wife and didn't feel quite right.On an unspecified date in (b)(6) 2017, after unknown latency, patient was experiencing adverse events swelling, very painful, very unstable and patient could barely walk immediately after this injection, and that night was icing, elevating, taking ibuprofen, was using a hard knee brace and a mobility device to get around as per his hcp since receiving this last injection.Patient did swell a little bit.Patient did no activities after this injection.Patient (circumference of right knee) was able to bare weight on right knee before injection and after injection, but very painful after injection had in the right knee pain level of 3 before injection and right knee pain level of 8 after injection.On an unknown date in (b)(6) 2017, after unknown latency, (1.5 months ago went) patient went to er with fever, had a type of infection, high wbc count, and been treated on & off, no antibiotics taken, not sure if related to synvisc one injection and tested for c-reactive protein and no fluid drained from right knee and patient denied hospitalization hcp's was treating with ibuprofen, elevation, ice, and had not fully recovered and still had constant pain.Patient got so much better results in the past.Corrective treatment: walker and mobility device for could barely walk immediately after the injection/ very unstable/ could not move; not reported for could not put weight on it; icing for can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen; icing, ibuprofen, hard knee brace for very painful/ worst pain/ still had constant pain; unspecified treatment for infection outcome: not recovered/ not resolved for device malfunction, can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen and very painful/ worst pain/ still had constant pain; unknown for rest of the events.Seriousness criteria: important medical event for device malfunction.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 would be completed, corrective and preventive actions would be implemented.Pharmacovigilance comment: sanofi company comment dated 29-jan-2018: this case concerns a patient who received treatment with synvisc one from recall lot and later experienced walking difficulty, weight bearing difficulty, stiff knees, knee pain, swelling of knees and infection.A temporal relationship can be established with the product administration.Furthermore, the concerned lot has been identified to have malfunction by the company and causal relationship of the events to the products cannot be excluded.

Event Description

This case is cross-referred to case: (b)(4) (same reporter).This unsolicited case from united states was received on (b)(6) 2018 from a patient's wife.This case concerns a 62 year old male patient who received treatment with synvisc one injection and later after unknown latency could barely walk immediately after the injection/ very unstable/ could not move, could not put weight on it, can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen, very painful/ worst pain/ still had constant pain, had infection and did not feel well and also, device malfunction was identified for the reported lot number.In the past patient had the past he has received 2 synvisc one injections in his left knee, 3 synvisc-one injections in the right knee, got cortisone injections in his spine, and in his left knee that was bone on bone.No relevant medical history, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patients initiated treatment with intra- articular synvisc one injection at a dose of 10 ml syringe (lot no.: 7rsl021; expiry not provided) (frequency: not provided) for osteoarthritis and tear in the knee.Patient didn't felt as bad.He had to take care of her wife and didn't feel quite right.On an unspecified date in (b)(6) 2017, after unknown latency, patient was experiencing adverse events swelling, very painful, very unstable and patient could barely walk immediately after this injection, and that night was icing, elevating, taking ibuprofen, was using a hard knee brace and a mobility device to get around as per his hcp since receiving this last injection.Patient did swell a little bit.Patient did no activities after this injection.Patient (circumference of right knee) was able to bare weight on right knee before injection and after injection, but very painful after injection had in the right knee pain level of 3 before injection and right knee pain level of 8 after injection.On an unknown date in nov-2017, after unknown latency, (1.5 months ago went) patient went to er with fever, had a type of infection, high wbc count, and been treated on & off, no antibiotics taken, not sure if related to synvisc one injection and tested for c-reactive protein and no fluid drained from right knee and patient denied hospitalization hcp's was treating with ibuprofen, elevation, ice, and had not fully recovered and still had constant pain.Patient got so much better results in the past.On an unknown date after unknown latency, the patient did not felt well but he needs to care for his wife.Corrective treatment: unknown for did not feel well; walker and mobility device for could barely walk immediately after the injection/ very unstable/ could not move; not reported for could not put weight on it; icing for can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen; icing, ibuprofen, hard knee brace for very painful/ worst pain/ still had constant pain; unspecified treatment for infection outcome: not recovered/ not resolved for device malfunction, can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen and very painful/ worst pain/ still had constant pain; unknown for rest of the events seriousness criteria: important medical event for device malfunction a global pharmaceutical technical complaint (ptc) was initiated with global ptc number: 52196 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 would be completed, corrective and preventive actions would be implemented.Follow up information was received on 06-feb-2018.Global ptc number was added additional information was received on 28-feb-2018 from the patient's wife.Related case id was added.Event of did not feel well was added with details.Clinical course was updated and text amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 28-feb-2018: the follow up information did not change the previous case assessment.This case concerns a patient who received treatment with synvisc one from recalled lot and later experienced walking difficulty, weight bearing difficulty, stiff knees, knee pain, swelling of knees and infection.A temporal relationship can be established with the product administration.Furthermore, the concerned lot has been identified to have malfunction by the company and causal relationship of the events to the products cannot be excluded.

Event Description

Could barely walk immediately after the injection/ very unstable/ could not move [walking difficulty] device malfunction [device malfunction] e.Coli infection [escherichia infection] very painful/ worst pain/ still had constant pain/pain is sharp, throbbing, aching [knee pain] did not feel well [feeling unwell] could not put weight on it [weight bearing difficulty] infection [infection] ([fever], [white blood cell count high]) did not get relief from injection [device ineffective] can't straighten leg [stiff knees] swelling/ did swell a bit/ swelled up/ still swollen [knee swelling] case narrative: this case is cross-referred to case: (b)(4).This unsolicited legal case from united states was received on 23-jan-2018 from a patient's wife.This case concerns a 62 year old male patient who received treatment with synvisc one injection and later after unknown latency could barely walk immediately after the injection/ very unstable/ could not move, could not put weight on it, can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen, very painful/ worst pain/ still had constant pain/ sharp, throbbing, stabbing, burning, aching; had infection and did not feel well, e.Coli infection, did not get relief from injection.Also, device malfunction was identified for the reported lot number.In the past patient had the past he has received 2 synvisc one injections in his left knee, 3 synvisc-one injections in the right knee, got cortisone injections in his spine, and in his left knee that was bone on bone.Concurrent conditions of fibromyalgia, osteoarthritis, anxiety disorder and hypertension.Past surgical history included tubes in ears, sinus, tooth extraction, eye/laser, cataract removal, posterior cruciate ligament repair, knee arthroscopy-menisectomy.Patient was a non-smoker.Concomitant medications included zolpidem tartrate; olopatadine hydrochloride (pataday); ibuprofen; ciclosporin (restasis); tramadol hydrochloride; alprazolam; nifedipine (nifedical); and enalapril maleate.On (b)(6) 2017, patients initiated treatment with intra- articular synvisc one injection at a dose of 10 ml syringe in his right knee (lot no.: 7rsl021; expiry not provided) (frequency: not provided) for osteoarthritis and tear in the knee.The injection was performed under sterile conditions using 2cc betamethasone, 2cc lidocaine and 2cc marcaine.The patient was informed that the numbing agent would last 2-3 hours and the cortisone may not begin to work for 3-4 days.Patient didn't felt as bad.He had to take care of her wife and didn't feel quite right.On an unspecified date in (b)(6) 2017, after unknown latency, patient was experiencing adverse events swelling, very painful, very unstable and patient could barely walk immediately after this injection, and that night was icing, elevating, taking ibuprofen, was using a hard knee brace and a mobility device to get around as per his hcp since receiving this last injection.Patient did swell a little bit.Patient did no activities after this injection.Patient (circumference of right knee) was able to bare weight on right knee before injection and after injection, but very painful after injection had in the right knee pain level of 3 before injection and right knee pain level of 8 after injection.On an unknown date in (b)(6) 2017, after unknown latency, (1.5 months ago went) patient went to er with fever, had a type of infection, high wbc count, and been treated on & off, no antibiotics taken, not sure if related to synvisc one injection and tested for c-reactive protein and no fluid drained from right knee and patient denied hospitalization hcp's was treating with ibuprofen, elevation, ice, and had not fully recovered and still had constant pain.Patient got so much better results in the past.On (b)(6) 2018, patient reported for follow up of her right knee pain and stated that he did not get any relief with the injection (latency: unknown).He reported that his pain was at 7 on a scale of 10 and at its worst was on 10, pain is sharp, throbbing, aching and was constant in nature, which resulted in the patient awakening from sleep and was related to activity.Further, patient had an e.Coli infection (latency: unknown) and was concerned that it may be related to the recall lot.The patient was reassured that the organism from the recall batch was not e.Coli.Prior to receiving the cortisone injection, 2ml of clear yellow fluid was withdrawn from his left knee.Further, cortisone injection was performed under sterile conditions using 2cc betamethasone, 2cc lidocaine and 2cc marcaine.The patient was informed that the numbing agent would last 2-3 hours and the cortisone may not begin to work for 3-4 days in his left knee.On (b)(6) 2018, patient reported for follow up of his left knee pain and was administered another cortisone injection under sterile conditions.He reported that his pain was 8 on a scale of 10 and was constant, sharp, stabbing, burning and aching in nature.On (b)(6) 2018, patient reported for follow up of his right knee pain and reported that his pain was 9 on 10, it was sharp, throbbing, stabbing, burning, aching in nature and was constant.Patient wanted to get bilateral cortisone injections.A cortisone injection was given, bilaterally under sterile conditions in both right and left knee using 2cc betamethasone, 2cc lidocaine and 2cc marcaine.The patient was informed that the numbing agent would last 2-3 hours and the cortisone may not begin to work for 3-4 days.On an unknown date after unknown latency, the patient did not felt well but he needs to care for his wife.Corrective treatment: unknown for did not feel well; walker and mobility device for could barely walk immediately after the injection/ very unstable/ could not move; not reported for could not put weight on it; icing for can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen; icing, ibuprofen, hard knee brace, cortisone injection for very painful/ worst pain/ still had constant pain/pain is sharp, throbbing, stabbing, burning, aching; unspecified treatment for infection.Outcome: not recovered/ not resolved for device malfunction, can't straighten leg, swelling/ did swell a bit/ swelled up/ still swollen and very painful/ worst pain/ still had constant pain/ sharp, throbbing, stabbing, burning, aching; unknown for rest of the events.Seriousness criteria: disability for could barely walk immediately after the injection/ very unstable/ could not move; medically significant for e.Coli infection; required intervention for very painful/ worst pain/ still had constant pain/pain is sharp, throbbing, stabbing, burning, aching, device malfunction.A global pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).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 would be completed, corrective and preventive actions would be implemented.Follow up information was received on 06-feb-2018.Global ptc number was added additional information was received on 28-feb-2018 from the patient's wife.Related case id was added.Event of did not feel well was added with details.Clinical course was updated and text amended accordingly.Additional information received on 07-feb-2019 from lawyer.Case classification of legal added.Medical history of fibromyalgia, osteoarthritis, anxiety disorder, hypertension, tubes in ears, sinus, tooth extraction, eye/laser, cataract removal, posterior cruciate ligament repair, knee arthroscopy-menisectomy added.Concomitant medications of zolpidem tartrate; olopatadine hydrochloride (pataday); ibuprofen; ciclosporin (restasis); tramadol hydrochloride; alprazolam; nifedipine (nifedical); and enalapril maleate added.Verbatim updated from very painful/ worst pain/ still had constant pain to very painful/ worst pain/ still had constant pain/ sharp, throbbing, stabbing, burning, aching and required intervention was added.Event of did not get relief from injection and e.Coli infection added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7265919
• MDR Text Key: 100273603
• Report Number: 2246315-2018-00252
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Treatment: ALPRAZOLAM (ALPRAZOLAM),TABLET; ENALAPRIL MALEATE (ENALAPRIL MALEATE),TABLET; IBUPROFEN (IBUPROFEN),TABLET; NIFEDICAL (NIFEDIPINE),TABLET; PATADAY (OLOPATADINE HYDROCHLORIDE),UNKNOWN; RESTASIS (CICLOSPORIN),UNKNOWN; SYNVISC ONE(PREV.); SYNVISC ONE(PREV.); TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE),TA; ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE),TABLET
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 127