Reported Reactions

Devices › Acid, hyaluronic, intraarticular

Device brand name · Moz

Synvisc: medical device reports filed with FDA

1,397 reports name it, 1998–2026. Manufacturer given most often on reports: Genzyme Ridgefield. Product code MOZ.

1,397
device reports naming the brand
0% of all MAUDE reports · about 50 a year
12
reports, 12 months to August 2026
23 in the 12 months before
0.6%
classified as malfunction
8.1% across the product code
1.6%
classified as death, as reported
23 reports · not verified by FDA

1,397 medical device reports received by FDA name the brand "Synvisc" (moz); the manufacturer given most often on reports is Genzyme Ridgefield; received from October 1998 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

12 reports arrived in the 12 months to August 2026, down 48% from 23 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 (91.6%), other (2.4%) and death (1.6%); 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 remains implanted (13.2%), insufficient device problem information (6.1%) and reaction (4.4%). 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

0713Sep 2021: 4Oct 2021: 3Nov 2021: 3Dec 2021: 32022Jan 2022: 5Feb 2022: 6Mar 2022: 4Apr 2022: 5May 2022: 2Jun 2022: 12Jul 2022: 10Aug 2022: 9Sep 2022: 7Oct 2022: 4Nov 2022: 4Dec 2022: 82023Jan 2023: 7Feb 2023: 10Mar 2023: 4Apr 2023: 1May 2023: 6Jun 2023: 7Jul 2023: 5Aug 2023: 13Sep 2023: 4Oct 2023: 1Nov 2023: 2Dec 2023: 22024Jan 2024: 3Feb 2024: 1Mar 2024: 3Apr 2024: 4May 2024: 5Jun 2024: 1Jul 2024: 0Aug 2024: 2Sep 2024: 0Oct 2024: 4Nov 2024: 5Dec 2024: 42025Jan 2025: 3Feb 2025: 2Mar 2025: 1Apr 2025: 1May 2025: 1Jun 2025: 0Jul 2025: 1Aug 2025: 1Sep 2025: 1Oct 2025: 2Nov 2025: 0Dec 2025: 12026Jan 2026: 0Feb 2026: 2Mar 2026: 1Apr 2026: 1May 2026: 1Jun 2026: 3Jul 2026: 0Aug 2026: 0

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

0581161998: 1519981999: 52000: 102001: 1520012002: 442003: 602004: 10020042005: 982006: 922007: 10320072008: 82009: 92010: 520102011: 32012: 52013: 4220132014: 612015: 392016: 5020162017: 532018: 712019: 8820192020: 1162021: 1132022: 7620222023: 622024: 322025: 1420252026: 8

Event type and report source

Event type, as classified on the report

Death1.6%23
Injury91.6%1,279
Malfunction0.6%9
Other2.4%34
Not given3.7%52

Who filed the report

Manufacturer report86.8%1,212
Voluntary report12.4%173
User facility report0%0
Distributor report0.9%12
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
Device remains implanted18413.2%2.6%
Insufficient device problem information856.1%23.5%
Reactiona reaction, type not specified624.4%1.7%
Patient-device incompatibilitythe device did not suit the patient523.7%9.2%
Device operates differently than expectedthe device behaved unexpectedly90.6%2.9%
Improper or incorrect procedure or method80.6%0.9%
Other (for use when an appropriate device code cannot be identified)50.4%0.2%
Unexpected therapeutic results50.4%0.3%
Microbial contamination of device30.2%2.1%
Patient device interaction problem30.2%0.5%
Therapeutic or diagnostic output failure30.2%0.5%
Device inoperablethe device could not be used20.1%0%
Device, or device fragments remain in patient20.1%0%
Labelling, instructions for use or training problem20.1%0.1%
Leak/splashthe device leaked20.1%0.1%
Replace20.1%0%
Aborted charge10.1%0%
Application interface becomes non-functional or program exits abnormally10.1%0%
Collapse10.1%0%
Complete blockage10.1%0%

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
Arthralgiajoint pain37727%
Painpain, site not specified33123.7%
Joint swellinga swollen joint31422.5%
Treatment with medication(s)30321.7%
Swellingswelling26318.8%
Other (for use when an appropriate patient code cannot be identified)21815.6%
Ambulation or postural difficulties17312.4%
Hospitalization required16211.6%
Therapy/non-surgical treatment, additional1329.4%
Appropriate clinical signs, symptoms and conditions term/code not available1168.3%
Pleural effusionfluid around the lung1047.4%
Inflammationinflammation1027.3%
Arthritis825.9%
Surgical procedure795.7%
Synovitis735.2%

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

In context

MeasureSynviscProduct code MOZAll MAUDE reports
Reports1,3978,42326,136,888
Share of that pool—16.6%0%
Classified as death, per 1,000 reports16379
Classified as injury91.6%66.3%36.2%
Classified as malfunction0.6%8.1%62.3%
Filed by the manufacturer86.8%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%
Synvisc Hylan G-F 20 Injection1,15600.2%
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 reports

How many FDA reports name Synvisc?

1,397 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.

What kinds of events are reported?

injury (91.6%), other (2.4%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device remains implanted (13.2%), insufficient device problem information (6.1%), reaction (4.4%), patient-device incompatibility (3.7%) and device operates differently than expected (0.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (86.8%), voluntary reports (12.4%) and distributor reports (0.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Synvisc 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.