Reported Reactions

Devices › Prosthesis, elbow, constrained, cemented

Device brand name · Disc ulna bearing kit

Discovery Elbow: medical device reports filed with FDA

451 reports name it, 2016–2023. Manufacturer given most often on reports: Encore Medical L P. Product code JDC.

451
device reports naming the brand
0% of all MAUDE reports · about 43 a year
0
reports, 12 months to August 2026
0 in the 12 months before
1.1%
classified as malfunction
6.4% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 451 reports that name the brand "Discovery Elbow" (disc ulna bearing kit), received between January 2016 and November 2023; the manufacturer given most often on reports is Encore Medical L P. 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 injury (98.9%) and malfunction (1.1%); across all prosthesis, elbow, constrained, cemented reports (product code JDC) death is recorded in 0.4% and malfunction in 6.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are loose or intermittent connection (25.9%), naturally worn (9.3%) and fracture (9.1%). The patient problems coded most often are failure of implant, bone fracture(s) 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

059Sep 2021: 9Oct 2021: 6Nov 2021: 7Dec 2021: 62022Jan 2022: 5Feb 2022: 6Mar 2022: 2Apr 2022: 5May 2022: 6Jun 2022: 4Jul 2022: 5Aug 2022: 7Sep 2022: 3Oct 2022: 7Nov 2022: 7Dec 2022: 42023Jan 2023: 0Feb 2023: 0Mar 2023: 3Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 1Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 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

039772016: 4020162017: 7220172018: 7520182019: 6320192020: 5920202021: 7720212022: 6120222023: 42023

Event type and report source

Event type, as classified on the report

Death0%0
Injury98.9%446
Malfunction1.1%5
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%451
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 3,077 reports carrying product code JDC. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Loose or intermittent connection11725.9%5.9%
Naturally worn429.3%4.7%
Fracturea broken bone419.1%9.1%
Insufficient device problem information224.9%16.6%
Breakthe device broke214.7%3.3%
Loosening of implant not related to bone-ingrowth214.7%6.6%
Device slipped153.3%2.6%
Device dislodged or dislocated92%3.7%
Unstable71.6%2.3%
Device operates differently than expectedthe device behaved unexpectedly61.3%0.6%
Contamination30.7%0.1%
Improper or incorrect procedure or method20.4%0.4%
Inadequacy of device shape and/or size20.4%0.4%
Material protrusion/extrusion20.4%0%
Corrodedthe device corroded10.2%0%
Degraded10.2%0.1%
Device handling problem10.2%0%
Difficult to insertthe device was hard to insert10.2%0.7%
Failure to adhere or bond10.2%2.6%
Loss of or failure to bond10.2%0.6%

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
Failure of implant5311.8%
Bone fracture(s)245.3%
Painpain, site not specified194.2%
Falla fall163.5%
Joint laxity122.7%
Appropriate clinical signs, symptoms and conditions term/code not available61.3%
Discomfortdiscomfort30.7%
Fracture, arm30.7%
Medical device site infectioninfection at the device site30.7%
Osteolysis30.7%
Perforation20.4%
Tissue damage20.4%
Ambulation or postural difficulties10.2%
Device embedded in tissue or plaque10.2%
Fluid discharge10.2%

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

In context

MeasureDiscovery ElbowProduct code JDCAll MAUDE reports
Reports4513,07726,136,888
Share of that pool—14.7%0%
Classified as death, per 1,000 reports049
Classified as injury98.9%92.9%36.2%
Classified as malfunction1.1%6.4%62.3%
Filed by the manufacturer100%99%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 JDC

BrandReportsLatest 12 monthsClassified as death
Unknown Humeral Stem162151.2%
Unknown Extremity15501.9%
Unk Liner3731210%

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 Discovery Elbow reports

How many FDA reports name Discovery Elbow?

451 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?

injury (98.9%) and malfunction (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

loose or intermittent connection (25.9%), naturally worn (9.3%), fracture (9.1%), insufficient device problem information (4.9%) and break (4.7%). 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 Discovery Elbow 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.