Reported Reactions

Devices › Acid, hyaluronic, intraarticular

Device brand name · Intra-articular hyaluronic acid

Synvisc Hylan G-F 20 Injection: medical device reports filed with FDA

1,156 reports name it, 2008–2013. Manufacturer given most often on reports: Genzyme Biosurgery Ridgefield. Product code MOZ.

1,156
device reports naming the brand
0% of all MAUDE reports · about 63 a year
0
reports, 12 months to August 2026
0 in the 12 months before
0%
classified as malfunction
8.1% across the product code
0.2%
classified as death, as reported
2 reports · not verified by FDA

FDA's MAUDE database holds 1,156 reports that name the brand "Synvisc Hylan G-F 20 Injection" (intra-articular hyaluronic acid), received between January 2008 and September 2013; the manufacturer given most often on reports is Genzyme Biosurgery Ridgefield. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 other (69.8%), injury (14.7%) and death (0.2%); 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 insufficient device problem information (58.1%), patient-device incompatibility (15.3%) and device operates differently than expected (9.3%). The patient problems coded most often are joint swelling, arthralgia and pain. 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

No report naming Synvisc Hylan G-F 20 Injection was received in the five years to August 2026; the latest was received in September 2013.

By year received

01633252008: 11120082009: 17520092010: 12720102011: 17220112012: 24620122013: 3252013

Event type and report source

Event type, as classified on the report

Death0.2%2
Injury14.7%170
Malfunction0%0
Other69.8%807
Not given15.3%177

Who filed the report

Manufacturer report100%1,156
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Insufficient device problem information67258.1%23.5%
Patient-device incompatibilitythe device did not suit the patient17715.3%9.2%
Device operates differently than expectedthe device behaved unexpectedly1089.3%2.9%
Improper or incorrect procedure or method111%0.9%
Device remains implanted50.4%2.6%
Fluid/blood leak20.2%0.1%
Malposition of device20.2%0%
Device handling problem10.1%0%
Device slipped10.1%0%
Excess flow or over-infusion10.1%0%
Human-device interface problem10.1%0%
Material opacification10.1%0%
Migration or expulsion of device10.1%0%
Noise, audible10.1%0%
Patient device interaction problem10.1%0.5%

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)ReportsShare
Joint swellinga swollen joint51444.5%
Arthralgiajoint pain34429.8%
Painpain, site not specified24521.2%
Synovitis21818.9%
Swellingswelling21618.7%
Arthritis21418.5%
Ambulation or postural difficulties14212.3%
Inflammationinflammation766.6%
Fever605.2%
Limited mobility of the implanted joint534.6%
Erythemaskin redness504.3%
Fluid discharge494.2%
Loss of range of motion453.9%
Edemaswelling from fluid433.7%
Hypersensitivity/allergic reaction433.7%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureSynvisc Hylan G-F 20 InjectionProduct code MOZAll MAUDE reports
Reports1,1568,42326,136,888
Share of that pool—13.7%0%
Classified as death, per 1,000 reports2379
Classified as injury14.7%66.3%36.2%
Classified as malfunction0%8.1%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Synvisc One1,916131.4%
Synvisc1,397121.6%
Euflexxa6712618.2%
Synvisc One Hylan G-F 20 Injection40000.3%
Orthovisc26546.8%
Hyalgan26603%
Synvisc One Synvisc One22201.8%
Synvisc Synvisc18501.1%
Hydrelle17600%
Restylane17060%

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 Hylan G-F 20 Injection reports

How many FDA reports name Synvisc Hylan G-F 20 Injection?

1,156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

other (69.8%), injury (14.7%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (58.1%), patient-device incompatibility (15.3%), device operates differently than expected (9.3%), improper or incorrect procedure or method (1%) and device remains implanted (0.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Synvisc Hylan G-F 20 Injection 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.