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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Capsular Contracture (1761); Loss of Range of Motion (2032); Arthralgia (2355); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Unable to bend or support standing [joint range of motion decreased]. Unable to stand/ unable to bend or support standing/ unable to getting up from a sitting position [difficulty in standing]. Muscle spasms [muscle spasms]. Unable to walking [unable to walk]. Severe swelling in left knees/ extreme swelling surrounding both knees [swelling of l knee]. Pain in left knees/ pain began under the kneecaps [aching (l) knee]. Case narrative: this case was cross linked to case (b)(4) (multiple device). Initial information received on 28-sep-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5102783 via patient. This case involves an unknown age and unknown gender patient who was unable to bend or support standing, unable to stand/ unable to bend or support standing/ unable to getting up from a sitting position, unable to walking, severe swelling in left knees/ extreme swelling surrounding both knees, pain in left knees/ pain began under the kneecaps and muscle spasms while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included levothyroxine; losartan; spironolactone; cetirizine; vitamin d not otherwise specified (nos); vitamins nos (multivitamins); and chlorphenamine maleate, paracetamol, phenylpropanolamine hydrochloride (cologen). In 2021, the patient started using hylan g-f 20, sodium hyaluronate injection (3 injection series) (strength: 16 mg/ 2 ml) ( indication , dose, route, frequency, lot: unknown) in left knee. On an unknown date in 2021 patient received second injection in left knee. On the day of second injection, the pain began under the kneecaps 7 hours after the injection (arthralgia) and continued to extreme swelling surrounding both knees (joint swelling) (latency: few days). The patient was unable to bend or support standing (joint range of motion decreased, dysstasia), walking (gait inability) and getting up from a sitting position (onset: 2021; latency: few days). Patient elevated iced and took ibuprofen and cyclobenzaprine for the pain and muscle spasms (onset: 2021; latency: unknown) but neither of those medication eliminated the pain, swelling or muscle spasms. The pain score was a 10 plus. No testing was done. All the events were believed to have caused serious injury (seriousness: medically significant). Action taken: unknown for all events. The patient was treated with ibuprofen and cyclobenzaprine for arthralgia and muscle spasms. Corrective treatment was not reported for other events outcome: unknown for all events. A product technical compliant was initiated on 28-sep-2021 with comet compliant id number: (b)(4) and results were pending same. Additional information was received on 28-sep-2021 from the quality department. Strength and formulation added. Global ptc number added. Text amended accordingly.
 
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Brand NameSYNVISC
Type of DeviceMOZ
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 Key12582596
MDR Text Key274942415
Report Number2246315-2021-00163
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
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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: 10/06/2021 Patient Sequence Number: 1
Treatment
CETIRIZINE (CETIRIZINE),UNKNOWN; COLOGEN,UNKNOWN; LEVOTHYROXINE (LEVOTHYROXINE),UNKNOWN; LOSARTAN (LOSARTAN),UNKNOWN; MULTIVITAMIN [VITAMINS NOS] (VITAMINS NOS),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; VIT D [VITAMIN D NOS] (VITAMIN D NOS),UNKNOWN
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