Reported Reactions

Devices › Prosthesis, hip, semi-constrained, metal/polymer, cemented

Device brand name · Implant

Exeter V40 Stem 44mm No 0: medical device reports filed with FDA

216 reports name it, 2007–2026. Manufacturer given most often on reports: Stryker Orthopaedics-Mahwah. Product code JDI.

216
device reports naming the brand
0% of all MAUDE reports · about 11 a year
8
reports, 12 months to August 2026
8 in the 12 months before
12.5%
classified as malfunction
7.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 216 reports that name the brand "Exeter V40 Stem 44mm No 0" (implant), received between March 2007 and August 2026; the manufacturer given most often on reports is Stryker Orthopaedics-Mahwah. Spellings of one product vary from report to report.

8 reports arrived in the 12 months to August 2026, close to the 8 of 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 (87.5%) and malfunction (12.5%); across all prosthesis, hip, semi-constrained, metal/polymer, cemented reports (product code JDI) death is recorded in 0.4% and malfunction in 7.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fracture (40.7%), break (19%) and insufficient device problem information (11.6%). The patient problems coded most often are injury, pain and ambulation or postural difficulties. 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

023Sep 2021: 1Oct 2021: 2Nov 2021: 2Dec 2021: 12022Jan 2022: 1Feb 2022: 1Mar 2022: 2Apr 2022: 1May 2022: 0Jun 2022: 1Jul 2022: 0Aug 2022: 0Sep 2022: 1Oct 2022: 2Nov 2022: 3Dec 2022: 12023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 1May 2023: 0Jun 2023: 1Jul 2023: 1Aug 2023: 1Sep 2023: 0Oct 2023: 2Nov 2023: 0Dec 2023: 12024Jan 2024: 2Feb 2024: 0Mar 2024: 1Apr 2024: 1May 2024: 0Jun 2024: 0Jul 2024: 1Aug 2024: 0Sep 2024: 1Oct 2024: 1Nov 2024: 1Dec 2024: 12025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 1May 2025: 0Jun 2025: 2Jul 2025: 0Aug 2025: 1Sep 2025: 0Oct 2025: 1Nov 2025: 1Dec 2025: 02026Jan 2026: 1Feb 2026: 1Mar 2026: 0Apr 2026: 0May 2026: 2Jun 2026: 0Jul 2026: 1Aug 2026: 1

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

010192007: 420072009: 62010: 720102011: 82012: 1120122013: 162014: 1320142015: 172016: 920162017: 182018: 1620182019: 192020: 1620202021: 152022: 1320222023: 72024: 920242025: 62026: 62026

Event type and report source

Event type, as classified on the report

Death0%0
Injury87.5%189
Malfunction12.5%27
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%216
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 70,618 reports carrying product code JDI. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Fracturea broken bone8840.7%3.7%
Breakthe device broke4119%2.7%
Insufficient device problem information2511.6%30.7%
Crackthe device cracked83.7%0.2%
Material integrity problema problem with the device material62.8%0.3%
Corrodedthe device corroded41.9%2.9%
Degraded41.9%1.4%
Device operates differently than expectedthe device behaved unexpectedly41.9%1.2%
Device dislodged or dislocated31.4%14.7%
Material deformation31.4%0.3%
Loss of osseointegration20.9%2.1%
Packaging problem20.9%0.3%
Compatibility problem10.5%0.1%
Component missing10.5%0.1%
Device contamination with chemical or other material10.5%0.1%
Device markings/labelling problema problem with the device markings or label10.5%0.1%
Device packaging compromised10.5%0.1%
Difficult to insertthe device was hard to insert10.5%0.6%
Difficult to removethe device was hard to remove10.5%0.2%
Fitting problem10.5%0.3%

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
Injurya physical injury6329.2%
Painpain, site not specified3013.9%
Ambulation or postural difficulties2813%
Bone fracture(s)167.4%
Falla fall167.4%
Inflammationinflammation73.2%
Reactiona reaction, type not specified73.2%
Failure of implant41.9%
Joint dislocationa dislocated joint41.9%
Hip fracturea broken hip20.9%
Metal related pathology20.9%
Discomfortdiscomfort10.5%
Edemaswelling from fluid10.5%
Erythemaskin redness10.5%
Foreign body reaction10.5%

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

In context

MeasureExeter V40 Stem 44mm No 0Product code JDIAll MAUDE reports
Reports21670,61826,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports049
Classified as injury87.5%91.3%36.2%
Classified as malfunction12.5%7.8%62.3%
Filed by the manufacturer100%98.4%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 JDI

BrandReportsLatest 12 monthsClassified as death
Articuleze M Head 36mm +1 53,431240.1%
Articuleze M Head 36mm +53,111240.1%
Unknown Hip Femoral Head5,0801760.7%
Articuleze M Head 36mm -21,661100.2%
Articuleze M Head 36mm +8 51,674110.1%
Unknown Hip Femoral Stem4,140790.8%
Unknown Hip2,30651.9%
Unknown Head2,2501030.7%
Unknown Stem1,857840.5%
Unknown liner2,255750.4%
Unknown Reconstructive Product2,57900.4%
Articul/Eze Ball 32 +1 Gr69550.1%
UNK Hip Femoral Head Metal728670.1%
Articul/Eze Ball 28 +1 5 Gr641200.3%
S-Rom M Head 36mm +082700%

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 Exeter V40 Stem 44mm No 0 reports

How many FDA reports name Exeter V40 Stem 44mm No 0?

216 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 8 in the latest 12 months.

What kinds of events are reported?

injury (87.5%) and malfunction (12.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (40.7%), break (19%), insufficient device problem information (11.6%), crack (3.7%) and material integrity problem (2.8%). 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 Exeter V40 Stem 44mm No 0 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.