Reported Reactions

Devices › Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Device brand name · 87hry

Enduron 10d 54od X 28id: medical device reports filed with FDA

203 reports name it, 2007–2023. Manufacturer given most often on reports: Depuy Orthopaedics. Product code LPH.

203
device reports naming the brand
0% of all MAUDE reports · about 10 a year
0
reports, 12 months to August 2026
0 in the 12 months before
1.5%
classified as malfunction
7.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

203 medical device reports received by FDA name the brand "Enduron 10d 54od X 28id" (87hry); the manufacturer given most often on reports is Depuy Orthopaedics; received from February 2007 to December 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (98.5%) and malfunction (1.5%); across all prosthesis, hip, semi-constrained, metal/polymer, porous uncemented reports (product code LPH) death is recorded in 0.2% and malfunction in 7.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are naturally worn (47.3%), implant, removal of (24.1%) and component(s), worn (16.3%). The patient problems coded most often are osteolysis, pain and surgical procedure, repeated. 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

012Sep 2021: 0Oct 2021: 1Nov 2021: 1Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 1Feb 2023: 1Mar 2023: 0Apr 2023: 2May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 12024Jan 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

014282007: 1620072008: 182009: 1520092010: 282011: 1120112012: 202013: 2220132014: 192015: 1020152016: 182017: 820172018: 32019: 420192021: 62023: 52023

Event type and report source

Event type, as classified on the report

Death0%0
Injury98.5%200
Malfunction1.5%3
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%203
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 90,251 reports carrying product code LPH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Naturally worn9647.3%6.1%
Implant, removal of4924.1%2.3%
Component(s), worn3316.3%0.4%
Dislocated146.9%0.9%
Device dislodged or dislocated115.4%17%
Insufficient device problem information83.9%19.2%
Explanted42%2.3%
Loose31.5%0.9%
Other (for use when an appropriate device code cannot be identified)31.5%0.3%
Replace21%1%
Device issuea problem with the device10.5%0.1%

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
Osteolysis6431.5%
Painpain, site not specified2612.8%
Surgical procedure, repeated63%
Arthralgiajoint pain10.5%
Discomfortdiscomfort10.5%
Foreign body, removal of10.5%
Surgical procedure, additional10.5%

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

In context

MeasureEnduron 10d 54od X 28idProduct code LPHAll MAUDE reports
Reports20390,25126,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports029
Classified as injury98.5%91.7%36.2%
Classified as malfunction1.5%7.5%62.3%
Filed by the manufacturer100%99.1%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 LPH

BrandReportsLatest 12 monthsClassified as death
Unknown Hip Acetabular Liners4,8142600.2%
Unknown Hip Acetabular Cup3,2151060.4%
Apex Hole Elim Positive Stop1,082200.4%
Pinn Can Bone Screw 6 5mmx25mm1,299320%
Unknown Hip Femoral Stem4,140790.8%
Unknown Hip Femoral Head5,0801760.7%
Pinn Can Bone Screw 6 5mmx20mm1,075190.3%
Pinn Can Bone Screw 6 5mmx30mm981220.3%
Altrx Neut 36idx52od638230%
UNK Hip Femoral Head Ceramic7201260.1%
Unknown Hip2,30651.9%
Trident 0 X3 Insert 36mm Id58500.2%
Altrx Neut 36idx54od553230%
Altrx Neut 32idx50od552210%
Altrx +4 10d 36idx52od544170.2%

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 Enduron 10d 54od X 28id reports

How many FDA reports name Enduron 10d 54od X 28id?

203 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 (98.5%) and malfunction (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

naturally worn (47.3%), implant, removal of (24.1%), component(s), worn (16.3%), dislocated (6.9%) and device dislodged or dislocated (5.4%). 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 Enduron 10d 54od X 28id 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.