Reported Reactions

Devices › Prosthesis, shoulder, hemi-, humeral, metallic uncemented

Device brand name · Delta xtend implants shoulder humeral cup

Dxtend Stand Pe Cup D38 +9mm: medical device reports filed with FDA

162 reports name it, 2008–2026. Manufacturer given most often on reports: Depuy France Sas 3003895575. Product code HSD.

162
device reports naming the brand
0% of all MAUDE reports · about 9 a year
5
reports, 12 months to August 2026
11 in the 12 months before
4.3%
classified as malfunction
15.3% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

162 medical device reports received by FDA name the brand "Dxtend Stand Pe Cup D38 +9mm" (delta xtend implants shoulder humeral cup); the manufacturer given most often on reports is Depuy France Sas 3003895575; received from April 2008 to April 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

5 reports arrived in the 12 months to August 2026, down 55% from 11 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 (95.7%) and malfunction (4.3%); across all prosthesis, shoulder, hemi-, humeral, metallic uncemented reports (product code HSD) death is recorded in 0.3% and malfunction in 15.3%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device dislodged or dislocated (22.2%), insufficient device problem information (5.6%) and fitting problem (0.6%). The patient problems coded most often are joint dislocation, not applicable 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

023Sep 2021: 0Oct 2021: 0Nov 2021: 1Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 1May 2022: 1Jun 2022: 0Jul 2022: 1Aug 2022: 0Sep 2022: 1Oct 2022: 1Nov 2022: 1Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 1Apr 2023: 2May 2023: 1Jun 2023: 0Jul 2023: 1Aug 2023: 1Sep 2023: 1Oct 2023: 1Nov 2023: 1Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 1Apr 2024: 0May 2024: 2Jun 2024: 1Jul 2024: 0Aug 2024: 3Sep 2024: 0Oct 2024: 1Nov 2024: 1Dec 2024: 02025Jan 2025: 1Feb 2025: 1Mar 2025: 2Apr 2025: 0May 2025: 0Jun 2025: 2Jul 2025: 1Aug 2025: 2Sep 2025: 0Oct 2025: 1Nov 2025: 0Dec 2025: 12026Jan 2026: 0Feb 2026: 1Mar 2026: 1Apr 2026: 1May 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

010192008: 620082009: 42010: 420102011: 72012: 820122013: 82014: 1020142015: 42016: 1720162017: 122018: 1920182019: 92020: 820202021: 82022: 620222023: 92024: 920242025: 112026: 32026

Event type and report source

Event type, as classified on the report

Death0%0
Injury95.7%155
Malfunction4.3%7
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%162
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 10,267 reports carrying product code HSD. 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 dislodged or dislocated3622.2%14.8%
Insufficient device problem information95.6%13.2%
Fitting problem10.6%1.4%
Naturally worn10.6%2.1%

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 dislocationa dislocated joint1811.1%
Not applicable116.8%
Painpain, site not specified53.1%
Bone fracture(s)10.6%
Falla fall10.6%

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

In context

MeasureDxtend Stand Pe Cup D38 +9mmProduct code HSDAll MAUDE reports
Reports16210,26726,136,888
Share of that pool—1.6%0%
Classified as death, per 1,000 reports039
Classified as injury95.7%81.6%36.2%
Classified as malfunction4.3%15.3%62.3%
Filed by the manufacturer100%98.8%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 HSD

BrandReportsLatest 12 monthsClassified as death
Dxtend Metaglene355140%
Dxtend Glenosphere Std D38mm32350%
Unknown Shoulder Metaglene305160.3%
Dxtend Stand Pe Cup D38 +3mm30780%
Dxtend Screw Lock D4 5x36mm245110%
Flexible Shaft W/Cir Connector152120%
Dxtend Screw No Lock D4 5x18mm199210%
Unknown Shoulder Implant25480.8%
Dxtend Glenosphere Std D42mm22730%
Unknown Shoulder Humeral Stems23981.7%
Dxtend Screw Lock D4 5x30mm192120%
Dxtend Glenosphere Ecc D42mm16400%
Dxtend Stand Pe Cup D38 +6mm19620%
Unknown Shoulder Glenosphere335240.3%
Delta Xtend2082050%

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 Dxtend Stand Pe Cup D38 +9mm reports

How many FDA reports name Dxtend Stand Pe Cup D38 +9mm?

162 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.

What kinds of events are reported?

injury (95.7%) and malfunction (4.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device dislodged or dislocated (22.2%), insufficient device problem information (5.6%), fitting problem (0.6%) and naturally worn (0.6%). 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 Dxtend Stand Pe Cup D38 +9mm 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.