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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number BRSL039C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)
Event Date 04/29/2022
Event Type  Injury  
Event Description
Septic knee/infection got worse and ended up in the hospital for two months [septic arthritis] ([knee swelling], [pain in knee], [condition aggravated], [injection site joint effusion], [arthrocentesis]). Had difficulty walking [walking difficulty]. Case narrative: initial information received on 03-aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient) from canada. This case involves a 77 years old male patient who had septic knee/infection got worse and ended up in the hospital for two months and had difficulty walking with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one]. The patient's past medical treatment included cortisone. The patient's past medical history, vaccination(s) and family history were not provided. In (b)(6) 2022, the patient received synvisc one injection 6 ml intra-articular (with unknown batch number, strength, frequency, expiry date) for osteoarthritis. Information on batch number was requested on (b)(6) 2022 the patient mentioned on the synvisc patient support line that he had a synvisc-one injection in the right knee on (b)(6) 2022 for osteoarthritis. The patient said he was fine until about midnight then his knee swelled up (joint swelling) (latency: same day), he was in pain (arthralgia) (latency: same day), had difficulty walking (gait disturbance) and he ended up with a septic knee (arthritis bacterial; medically significant) (latency unknown). The next day he returned to the clinic where he was provided pain killers and anti-inflammatories. The following day his knee was worse (condition aggravated) (latency unknown), he then again returned and had fluids removed from his (knee injection site joint effusion), (arthrocentesis). The patient went to the hospital on the 30th some testing was done, was sent home for three days, infection got worse and ended up in the hospital for two months. Patient has had 4 surgeries since the injection. He now has half a knee waiting for the infection to clear up and to have a complete knee surgery. Patient also took antibiotics intravenously twice a day and had a knee cleansing to remove as much of the infection as possible. Patient said he was receiving cortisone injections previously. Corrective treatment: pain killers, anti-inflammatories, antibiotics and surgery. Action taken: not applicable for the events. Outcome: not recovered for the events. Seriousness criteria: medically significant. A product technical complaint (ptc) was initiated, and the results were pending for the same.
 
Manufacturer Narrative
(b)(6) comment dated (b)(6) 2022: this case involves a patient had septic knee/infection got worse and ended up in the hospital for two months, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). Based on the available information, causal relationship between the events and suspect product could not be denied. However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.
 
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Brand NameSYNVISC ONE
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 Key15204018
MDR Text Key297685990
Report Number2246315-2022-00096
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 Study,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberBRSL039C
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: 08/10/2022 Patient Sequence Number: 1
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