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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Fall (1848); Arthralgia (2355); No Code Available (3191)
Event Type  Injury  
Event Description
This sponsored solicited case from was received on (b)(6) 2018 from a patient via patient support program. Patient id: (b)(6); country: united states study title: sanofi patient connection this case concerns a (b)(6) female patient who received treatment with synvisc one and after unknown latency knees becoming infected; after 47 days had a fall, after 1 day not be able to move for three days, legs became weak, few hours later was hurting/extreme pain, had inability to walk for 48 hours; after unknown latency had extreme leg numbness, felt worse and disoriented. Event of device malfunction was identified in the case. The patient had mild diabetes, severe arthritis and sciatica. Concomitant medications included omeprazole for reflux, ramipril for blood pressure and buspirone for anxiety. No past drugs were reported. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, batch/lot number 7rsl021 and expiry date: unknown) once in each knee for pain in both legs. The same day, few hours after first dose of synvisc one, the patient experienced extreme pain, inability to walk for 48 hours, felt worse after the procedure. On (b)(6) 2017, one day after the synvisc-one was administered, patient had an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting. On (b)(6) 2017, 47 days after first dose of synvisc one, patient had a fall followed by hospitalization. The patient proceeded to get worse until this fall and had to be hospitalized. On unknown dates, after unknown latencies, the patient at that time had extreme leg numbness and was disoriented. Treatment included two different antibiotics (unspecified) and calling her doctor for a hospitalization following a fall, having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting. The having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting were ongoing. It was unknown if the hospitalization following a fall was ongoing or resolved. Patient reported that the day she received her injections, she came home and laid down on the couch and could not get up of move for three days. Patient reported her doctor told her there was a product recall of the synvisc-one, that she was hurting before but not like this; patient could not get really anything done to legs now. Patient also stated that she had heard other people that got the injections and just did great. On an unknown date, latency unknown, patient experienced a reaction to synvisc- one characterized by her knees becoming infected. Treatment included receiving an antibiotic(unspecified) that was the wrong antibiotic and switching to another antibiotic(unspecified) for a reaction to synvisc-one characterized by her knees becoming infected. It was unknown to reporter if a reaction to synvisc-one characterized by her knees becoming infected was ongoing. It was unknown to reporter if the consumer has a history of this event. It is unknown to reporter if the synvisc-one was ongoing. Corrective treatment: ciprofloxacin hydrochloride (ciprofloxacin) and hydrocodone for knees becoming infected; not reported for rest all events outcome: unknown for knees becoming infected, device malfunction, extreme leg numbness, inability to walk for 48 hours; not recovered for rest events a pharmaceutical technical complaint was initiated and results for the same were received. 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Reporter causality: not reported for all events company causality: associated for device malfunction; not associated for rest all events seriousness criterion: important medical event for knees becoming infected; hospitalization for device malfunction, fall, not be able to move for three days, legs became weak and hurting/extreme pain additional information was received on (b)(6) 2018. Investigation summary and gptc number was added. Text was amended accordingly. Additional information was received on (b)(6) 2018 from the patient's granddaughter. Suspect product lot number was added. Additional events of device malfunction, felt worse, disoriented, inability to walk for 48 hours and extreme leg numbness were added. Event term of hurting was updated to hurting/extreme pain. Outcome of fall was updated from unknown to not recovered and its event start date was updated. Corrective treatment of knees becoming infected was added. Medical history, concomitant medications and concurrent conditions were added. Suspect product therapy regimen was updated. Clinical course was updated and text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 28-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot. The events are temporally related to device. Moreover, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
 
Event Description
This sponsored solicited case from was received on 27- feb-2018 from a patient via patient support program. Patient id: (b)(6); country: united states. Study title: (b)(6). This case concerns a (b)(6) female patient who received treatment with synvisc one and after unknown latency knees becoming infected; after 47 days had a fall, after 1 day not be able to move for three days, legs became weak, few hours later was hurting/extreme pain, had inability to walk for 48 hours; after unknown latency had extreme leg numbness, felt worse and disoriented. Also device malfunction was reported for the same lot. Patient also had severe pain and couldn't move legs on the same day. The patient had mild diabetes, severe arthritis, and sciatica. Concomitant medications included omeprazole for reflux, ramipril for blood pressure and buspirone for anxiety, metformin hydrochloride (metformin) for diabetes and omeprazole for digestion. No past drugs were reported. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection (dose, batch/lot number 7rsl021 and expiry date: unknown) once in each knee for pain in both legs. The same day, few hours after first dose of synvisc one, the patient experienced extreme, severe pain, couldn't move legs, inability to walk for 48 hours, felt worse after the procedure. On (b)(6) 2017, one day after the synvisc-one was administered, patient had an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting. On (b)(6) 2017, 47 days after first dose of synvisc one, patient had a fall followed by hospitalization. The patient proceeded to get worse until this fall and had to be hospitalized. On unknown dates, after unknown latencies, the patient at that time had extreme leg numbness and was disoriented. Treatment included two different antibiotics (unspecified) and calling her doctor for a hospitalization following a fall, having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting. The having an injection in both of her knees that caused her to not be able to move for three days, her legs became weak, and "it was like they went dead on me", and she was hurting were ongoing. It was unknown if the hospitalization following a fall was ongoing or resolved. Patient reported that the day she received her injections, she came home and laid down on the couch and could not get up of move for three days. Patient reported her doctor told her there was a product recall of the synvisc-one, that she was hurting before but not like this; patient could not get really anything done to legs now. Patient also stated that she had heard other people that got the injections and just did great. On an unknown date, latency unknown, patient experienced a reaction to synvisc-one characterized by her knees becoming infected. Treatment included receiving an antibiotic(unspecified) that was the wrong antibiotic and switching to another antibiotic(unspecified) for a reaction to synvisc-one characterized by her knees becoming infected. It was unknown to reporter if a reaction to synvisc-one characterized by her knees becoming infected was ongoing. It was unknown to reporter if the consumer has a history of this event. It is unknown to reporter if the synvisc- one was ongoing. Corrective treatment: ciprofloxacin hydrochloride (ciprofloxacin) and hydrocodone for knees becoming infected; not reported for rest all events. Outcome: unknown for knees becoming infected, device malfunction, extreme leg numbness, inability to walk for 48 hours; not recovered for rest events a pharmaceutical technical complaint 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Reporter causality: not reported for all events. Company causality: associated for device malfunction; not associated for rest all events seriousness criterion: important medical event for knees becoming infected; hospitalization for device malfunction, fall, not be able to move for three days, legs became weak and hurting/extreme pain additional information was received on 06-mar-2018. Investigation summary and gptc number was added. Text was amended accordingly. Additional information was received on 28-mar-2018 from the patient's granddaughter. Suspect product lot number was added. Additional events of device malfunction, felt worse, disoriented, inability to walk for 48 hours and extreme leg numbness were added. Event term of hurting was updated to hurting/extreme pain. Outcome of fall was updated from unknown to not recovered and its event start date was updated. Corrective treatment of knees becoming infected was added. Medical history, concomitant medications and concurrent conditions were added. Suspect product therapy regimen was updated. Clinical course was updated and text was amended accordingly. Follow up information was received on 06-apr-2018. Global ptc number was added. Text amended accordingly. Additional information was received on 10-apr-2018 from patient. Additional events of severe pain and couldn't move legs were added along with details. Concomitant medications (metformin hydrochloride and omeprazole) were added. Clinical course was updated and text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 10-apr-2018: the new follow up information received does not change previous case assessment. This case concerns a patient who has received synvisc one injection from the recalled lot. The events are temporally related to device. Moreover, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
MDR Report Key7450070
MDR Text Key106271289
Report Number2246315-2018-00445
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,study
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/23/2018 Patient Sequence Number: 1
Treatment
ALTACE (RAMIPRIL),CAPSULE; ASPIRIN 81 (ACETYLSALICYLIC ACID),TABLET; BUSPIRONE (BUSPIRONE),; BUSPIRONE(CON.) START; BUSPIRONE(CON.) START; BUSPIRONE(CON.) STOP; BUSPIRONE(CON.) STOP; MELOXICAM (MELOXICAM),TABLET; METFORMIN (METFORMIN),; METFORMIN(CON.)-START; METFORMIN(CON.)-STOP-UNKNOWN; OMEPRAZOLE (OMEPRAZOLE),; OMEPRAZOLE(CON.) ONGOING; OMEPRAZOLE(CON.) ONGOING; OMEPRAZOLE(CON.)-START; OMEPRAZOLE(CON.)-STOP-UNKNOWN; RAMIPRIL (RAMIPRIL),; RAMIPRIL(CON.) START; RAMIPRIL(CON.) START; RAMIPRIL(CON.) STOP; RAMIPRIL(CON.) STOP; ZOCOR (SIMVASTATIN),TABLET
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