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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 Arthralgia (2355); No Code Available (3191)
Event Date 11/01/2017
Event Type  Injury  
Event Description
Device malfunction. Ambulating using a walker. Bilateral knee pain. Spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection (unevaluable event). Case narrative: this unsolicited legal case from united states was received on (b)(6) 2018 from a physician. This case involves a (b)(6) female patient who received treatment with synvisc one and later after unknown latency ambulating using a walker, bilateral knee pain and spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection. Device malfunction was also reported with the lot number medical history was significant for hip degenerative joint disease, knee degenerative joint disease, appendectomy, c-section, left total hip replacement and hysterectomy. Concurrent condition included primary osteoarthritis of both knees. The patient drinks alcohol daily, never smoked tobacco. The patient was active with no formal exercise. Concomitant medications included carvedilol, gabapentin, levothyroxine sodium (levothyroxine), meloxicam, nabumetone, hydrocodone bitartrate/paracetamol (norco), tramadol hydrochloride (tramadol) and triamterene. Relevant past drug was not reported on (b)(6) 2017, the patient received treatment with intra-articular injection of synvisc one (dosing regimen: not reported; batch/lot number: 7rsl021 and expiry date: may-2020) in both knees for primary osteoarthritis of left knee and right knee. The risks, benefits and complications of injections were discussed with the patient. The patient understood, agreed and wished to proceed. Both of the patient's legs were prepped with betadine. Under sterile conditions an injection was given to each with a mixture of 2 cc of 1% lidocaine, 6 cc of 1% marcaine with epinephrine and 2 cc of depo-medrol. A sterile band-aid was placed over the injection site. The patient tolerated the procedure well. On (b)(6) 2017, patient presented for follow-up of the bilateral synvisc one injections given to her. She spent 3-1/2 days in the hospital because reaction to this particular lot of medication. The patient was better now. She was ambulating using a walker. The patient knew that ultimately she would benefit from total knee arthroplasty. It was also reported that the pain was improving in both knees secondary to reaction to the visco supplementation injection. Corrective treatment: methylprednisolone acetate (depo-medrol) for ambulating using a walker and bilateral knee pain. Outcome: recovering for all events (except for spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection). A pharmaceutical technical complaint was initiated with gptc 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 (b)(6) 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 hospitalization, disability and required intervention for device malfunction; disability and required intervention for ambulating using a walker; required intervention for bilateral knee pain; required hospitalization for spent 3-1/2 days in hospital because reaction to this particular lot of medication/reaction to visco supplementation injection. Follow-up was received on 18-may-2018. Gptc number was added.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key7583421
MDR Text Key110526518
Report Number2246315-2018-00484
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 06/08/2018 Patient Sequence Number: 1
Treatment
CARVEDILOL (CARVEDILOL),TABLET; GABAPENTIN (GABAPENTIN),CAPSULE; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; MELOXICAM (MELOXICAM),TABLET; NABUMETONE (NABUMETONE),TABLET; NORCO (HYDROCODONE BITARTRATE, PARACETAMOL),TABLET; TRAMADOL (TRAMADOL),TABLET; TRIAMTERENE (TRIAMTERENE),TABLET
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