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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Lot Number 7RSL021
Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Fever (1858); Pain (1994); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 01/01/2017
Event Type  malfunction  
Event Description
Based on the information received on 22-nov-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction. This unsolicited case from united states was received on 16-nov-2017 from physician. This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and on the same day had pain/ right knee pain, swelling/ right knee swelling; after one day had knee aspirated/ right knee drained; after two days had low grade fever, redness. Also, device malfunction was identified for the reported lot number. No relevant past drugs and concurrent conditions were reported. Patient had high blood pressure. Patient had no known allergies. Concomitant medications included esomeprazole, doxepin and ciclosporin (restasis). On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, one dosage form once (batch/lot number: 7rsl021 and expiration date: may- 2020; indication: not provided) in right knee. On the same day of receiving injection, in the evening patient reported pain/swelling. On (b)(6) 2017, patient right knee was aspirated (80 cc fluid was sent for lab), steroid and methylprednisolone(medrol) dose pack was given. Lab test cultures showed no growth within 72 hours. Gram stain showed rare white blood cells. On the same day, synovial fluid analysis was done. No crystals were seen under normal or polarized light. Fluid was clear and color was yellow; nucleated cells was 2138 cell/mcl (range: 0-200), lymphocytes was 28 percent and macrophages was 4 percent. On (b)(6) 2017, after 2 days of receiving synvisc one injection, patient had redness and low grade fever. Doctor was thinking he might have to do a possible scope washout. On (b)(6) 2017, patient underwent right knee arthroscopy/ drained. Patient was doing well since and was till following up post operation. Corrective treatment: steroid, methylprednisolone(medrol) dose pack, right knee arthroscopy for pain/ right knee pain; 88 cc of fluid aspirated, steroid, medrol dose pack, right knee arthroscopy for knee aspirated/ right knee drained; steroid, medrol dose pack, fluid was drained, right knee arthroscopy for swelling/ right knee swelling; not reported for rest events outcome: not recovered for pain/ right knee pain; knee aspirated/ right knee drained, swelling/ right knee swelling; unknown for rest events a 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: required intervention for device malfunction, pain/ right knee pain, knee aspirated/ right knee drained, swelling/ right knee swelling additional information was received on 22-nov-2017. Global ptc number and ptc results were added. An additional event of device malfunction was added with details. Clinical course was updated and text was amended accordingly. Follow up was received on 15-dec-2017. No new information was received. Additional information was received on 27-dec-2017. Verbatim was updated for the event of pain to pain/ right knee pain; swelling to swelling/ right knee swelling; outcome updated. Event of knee aspirated/ right knee drained was added along with its details. Seriousness criterion of required intervention was updated to event of device malfunction and added to events of pain/ right knee pain, knee aspirated/ right knee drained, swelling/ right knee swelling. Start date was updated for the event for pain/ right knee pain and swelling/ right knee swelling; corrective treatment added. Medical history and concomitant medications added. Clinical course was updated and text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 27-dec-2017: this case concerns a female patient who has experienced low grade fever, localized erythema, right knee pain, effusion (r) knee, and right knee swelling after receiving synvisc one injection from the recalled lot. Patient underwent right knee arthroscopy. Based on the available information, temporal relationship can be established between the event and suspect product. Additionally, as the concerned lot number has been identified to have malfunction by the company. Hence, causal relationship of the events to the products cannot be excluded.
 
Event Description
Based on the information received on 22-nov-2017 the case initially processed as non-serious has been updated to serious because of addition of a serious event of device malfunction. This unsolicited case from united states was received on (b)(6) 2017 from physician. This case concerns a (b)(6) year old female patient who received treatment with synvisc one injection and after two days had low grade fever, pain, redness, swelling and 80cc fluid from knee also, device malfunction was identified for the reported lot number. No relevant concomitant medications, past drugs, medical history and concurrent conditions were reported. On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection, once (batch/lot number: 7rsl021; dose, indication and expiration date: not provided) in right knee. On (b)(6) 2017, after 2 days of receiving synvisc one injection, patient reported pain, swelling, redness and low grade fever. Doctor was thinking he might have to do a possible scope washout. It was reported that doctor aspirated 80cc fluid from knee today. Corrective treatment: not reported for all events. Outcome: unknown for all events. A 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: important medical event for device malfunction. Additional information was received on 22-nov-2017. Global ptc number and ptc results were added. An additional event of device malfunction was added with details. Clinical course was updated and text was amended accordingly. Pharmacovigilance comment: sanofi company comment dated 20-dec-2017: this case concerns a patient who has experienced low grade fever, localized erythema, right knee pain, effusion (r) knee, and right knee swelling after receiving synvisc one injection from the recalled lot. Based on the available information, temporal relationship can be established between the event and suspect product. Additionally, as the concerned lot number has been identified to have malfunction by the company. Hence, causal relationship of the events to the products cannot be excluded.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
MDR Report Key7144376
MDR Text Key281984147
Report Number2246315-2017-00341
Device Sequence Number0
Product Code MOZ
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/16/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/27/2017
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 12/22/2017 Patient Sequence Number: 1
Treatment
DOXEPIN(CON.); ESOMEPRAZOLE(CON.); RESTASIS(CON.)
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