Devices › Acid, hyaluronic, intraarticular
Device brand name · Moz
Synvisc One: medical device reports filed with FDA
1,916 reports name it, 2009–2026. Manufacturer given most often on reports: Genzyme Biosurgery Ridgefield. Product code MOZ.
- 1,916
- device reports naming the brand
- 0% of all MAUDE reports · about 112 a year
- 13
- reports, 12 months to August 2026
- 34 in the 12 months before
- 26.5%
- classified as malfunction
- 8.1% across the product code
- 1.4%
- classified as death, as reported
- 27 reports · not verified by FDA
FDA's MAUDE database holds 1,916 reports that name the brand "Synvisc One" (moz), received between June 2009 and February 2026; the manufacturer given most often on reports is Genzyme Biosurgery Ridgefield. Spellings of one product vary from report to report.
13 reports arrived in the 12 months to August 2026, down 62% from 34 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (70.6%), malfunction (26.5%) and death (1.4%); across all acid, hyaluronic, intraarticular reports (product code MOZ) death is recorded in 3.7% and malfunction in 8.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device contamination with biological material (28%), microbial contamination of device (9%) and insufficient device problem information (7%). The patient problems coded most often are arthralgia, pain and joint swelling. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,423 reports carrying product code MOZ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device contamination with biological material | 536 | 28% | 6.4% |
| Microbial contamination of device | 173 | 9% | 2.1% |
| Insufficient device problem information | 135 | 7% | 23.5% |
| Nonstandard device | 86 | 4.5% | 1.2% |
| Patient-device incompatibilitythe device did not suit the patient | 60 | 3.1% | 9.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 19 | 1% | 2.9% |
| Contamination | 7 | 0.4% | 0.2% |
| Loss of data | 5 | 0.3% | 0.1% |
| Unexpected therapeutic results | 5 | 0.3% | 0.3% |
| Improper or incorrect procedure or method | 3 | 0.2% | 0.9% |
| Contamination of device ingredient or reagent | 2 | 0.1% | 0.1% |
| Therapeutic or diagnostic output failure | 2 | 0.1% | 0.5% |
| Defective devicethe device was defective | 1 | 0.1% | 0% |
| Device contaminated during manufacture or shipping | 1 | 0.1% | 0% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.1% | 0.1% |
| Difficult to insertthe device was hard to insert | 1 | 0.1% | 0% |
| Inaccurate delivery | 1 | 0.1% | 0% |
| Leak/splashthe device leaked | 1 | 0.1% | 0.1% |
| Malposition of device | 1 | 0.1% | 0% |
| Product quality problem | 1 | 0.1% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Arthralgiajoint pain | 633 | 33% |
| Painpain, site not specified | 555 | 29% |
| Joint swellinga swollen joint | 524 | 27.3% |
| Swellingswelling | 384 | 20% |
| Joint disorder | 245 | 12.8% |
| Ambulation or postural difficulties | 238 | 12.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 143 | 7.5% |
| Arthritis | 134 | 7% |
| Reaction, injection site | 100 | 5.2% |
| Erythemaskin redness | 92 | 4.8% |
| Inflammationinflammation | 91 | 4.7% |
| Hypersensitivity/allergic reaction | 82 | 4.3% |
| Loss of range of motion | 68 | 3.5% |
| Bacterial infectiona bacterial infection | 61 | 3.2% |
| Fever | 54 | 2.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Synvisc One | Product code MOZ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,916 | 8,423 | 26,136,888 |
| Share of that pool | — | 22.7% | 0% |
| Classified as death, per 1,000 reports | 14 | 37 | 9 |
| Classified as injury | 70.6% | 66.3% | 36.2% |
| Classified as malfunction | 26.5% | 8.1% | 62.3% |
| Filed by the manufacturer | 94.7% | 77.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MOZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Synvisc | 1,397 | 12 | 1.6% |
| Synvisc Hylan G-F 20 Injection | 1,156 | 0 | 0.2% |
| Euflexxa | 671 | 26 | 18.2% |
| Synvisc One Hylan G-F 20 Injection | 400 | 0 | 0.3% |
| Orthovisc | 265 | 4 | 6.8% |
| Hyalgan | 266 | 0 | 3% |
| Synvisc One Synvisc One | 222 | 0 | 1.8% |
| Synvisc Synvisc | 185 | 0 | 1.1% |
| Hydrelle | 176 | 0 | 0% |
| Restylane | 170 | 6 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Synvisc One reports
How many FDA reports name Synvisc One?
1,916 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
injury (70.6%), malfunction (26.5%) and death (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device contamination with biological material (28%), microbial contamination of device (9%), insufficient device problem information (7%), nonstandard device (4.5%) and patient-device incompatibility (3.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (94.7%) and voluntary reports (5.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Synvisc One was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.