Reported Reactions

Devices › Acid, hyaluronic, intraarticular

Device brand name · Sodium hyaluronate for intra articulate injection

Orthovisc: medical device reports filed with FDA

265 reports name it, 2008–2025. Manufacturer given most often on reports: Anika Therapeutics. Product code MOZ.

265
device reports naming the brand
0% of all MAUDE reports · about 15 a year
4
reports, 12 months to August 2026
7 in the 12 months before
9.8%
classified as malfunction
8.1% across the product code
6.8%
classified as death, as reported
18 reports · not verified by FDA

265 medical device reports received by FDA name the brand "Orthovisc" (sodium hyaluronate for intra articulate injection); the manufacturer given most often on reports is Anika Therapeutics; received from April 2008 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

4 reports arrived in the 12 months to August 2026, down 43% from 7 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 (58.1%), other (24.9%) and malfunction (9.8%); 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 (23.4%), patient-device incompatibility (7.9%) and device operates differently than expected (4.5%). The patient problems coded most often are pain, swelling and itching sensation. 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

02040Sep 2021: 0Oct 2021: 1Nov 2021: 0Dec 2021: 12022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 2Jun 2022: 2Jul 2022: 0Aug 2022: 1Sep 2022: 0Oct 2022: 1Nov 2022: 0Dec 2022: 12023Jan 2023: 3Feb 2023: 4Mar 2023: 1Apr 2023: 3May 2023: 40Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 1Oct 2023: 1Nov 2023: 0Dec 2023: 12024Jan 2024: 0Feb 2024: 0Mar 2024: 2Apr 2024: 2May 2024: 1Jun 2024: 0Jul 2024: 5Aug 2024: 3Sep 2024: 1Oct 2024: 1Nov 2024: 0Dec 2024: 02025Jan 2025: 1Feb 2025: 0Mar 2025: 0Apr 2025: 1May 2025: 1Jun 2025: 0Jul 2025: 1Aug 2025: 1Sep 2025: 1Oct 2025: 2Nov 2025: 0Dec 2025: 12026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 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

027542008: 620082009: 62010: 920102011: 172012: 2420122013: 282014: 720142015: 162016: 1720162017: 162018: 1320182019: 52020: 920202021: 72022: 720222023: 542024: 1520242025: 9

Event type and report source

Event type, as classified on the report

Death6.8%18
Injury58.1%154
Malfunction9.8%26
Other24.9%66
Not given0.4%1

Who filed the report

Manufacturer report84.2%223
Voluntary report15.8%42
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 information6223.4%23.5%
Patient-device incompatibilitythe device did not suit the patient217.9%9.2%
Device operates differently than expectedthe device behaved unexpectedly124.5%2.9%
Off-label use103.8%1.4%
Breakthe device broke83%0.6%
Lack of effect31.1%0.1%
Fluid/blood leak20.8%0.1%
Missing value reason20.8%0%
Connection problema connection problem10.4%0%
Contamination10.4%0.2%

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
Painpain, site not specified7327.5%
Swellingswelling4717.7%
Itching sensation166%
Rashskin rash166%
Ambulation or postural difficulties145.3%
Reactiona reaction, type not specified134.9%
Erythemaskin redness103.8%
Nauseafeeling sick83%
Hypersensitivity/allergic reaction62.3%
Swelling/ edema62.3%
Dyspneashortness of breath51.9%
Fever51.9%
Headachehead pain51.9%
Joint swellinga swollen joint51.9%
Arthralgiajoint pain41.5%

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

In context

MeasureOrthoviscProduct code MOZAll MAUDE reports
Reports2658,42326,136,888
Share of that pool—3.1%0%
Classified as death, per 1,000 reports68379
Classified as injury58.1%66.3%36.2%
Classified as malfunction9.8%8.1%62.3%
Filed by the manufacturer84.2%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%
Synvisc Hylan G-F 20 Injection1,15600.2%
Euflexxa6712618.2%
Synvisc One Hylan G-F 20 Injection40000.3%
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 Orthovisc reports

How many FDA reports name Orthovisc?

265 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.

What kinds of events are reported?

injury (58.1%), other (24.9%) and malfunction (9.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (23.4%), patient-device incompatibility (7.9%), device operates differently than expected (4.5%), off-label use (3.8%) and break (3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (84.2%) and voluntary reports (15.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Orthovisc 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.