Reported Reactions

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

Device brand name · Total hip replacement

Unknown Depuy Duraloc Liner: medical device reports filed with FDA

264 reports name it, 2006–2017. Manufacturer given most often on reports: Depuy Orthopaedics. Product code LPH.

264
device reports naming the brand
0% of all MAUDE reports · about 13 a year
0
reports, 12 months to August 2026
0 in the 12 months before
0.4%
classified as malfunction
7.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 264 reports that name the brand "Unknown Depuy Duraloc Liner" (total hip replacement), received between March 2006 and November 2017; the manufacturer given most often on reports is Depuy Orthopaedics. 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 (99.6%) and malfunction (0.4%); 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 (61.4%), device dislodged or dislocated (15.5%) and insufficient device problem information (10.2%). The patient problems coded most often are osteolysis, pain and fall. 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

No report naming Unknown Depuy Duraloc Liner was received in the five years to August 2026; the latest was received in November 2017.

By year received

034682006: 620062008: 72009: 1420092010: 452011: 3420112012: 682013: 2920132014: 392015: 1320152016: 62017: 32017

Event type and report source

Event type, as classified on the report

Death0%0
Injury99.6%263
Malfunction0.4%1
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%264
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 worn16261.4%6.1%
Device dislodged or dislocated4115.5%17%
Insufficient device problem information2710.2%19.2%
Implant, removal of134.9%2.3%
Component(s), worn114.2%0.4%
Loss of osseointegration51.9%4.5%
Breakthe device broke20.8%1.6%
Dislocated20.8%0.9%
Computer system security problem10.4%0%
Disassembly10.4%1.4%
Fracturea broken bone10.4%4.4%
Loss of or failure to bond10.4%0.8%
Migration or expulsion of device10.4%1%
Noise, audible10.4%1.4%

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
Osteolysis8231.1%
Painpain, site not specified3914.8%
Falla fall31.1%
Bone fracture(s)20.8%
Foreign body reaction10.4%
Host-tissue reaction10.4%

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

In context

MeasureUnknown Depuy Duraloc LinerProduct code LPHAll MAUDE reports
Reports26490,25126,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports029
Classified as injury99.6%91.7%36.2%
Classified as malfunction0.4%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 Unknown Depuy Duraloc Liner reports

How many FDA reports name Unknown Depuy Duraloc Liner?

264 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 (99.6%) and malfunction (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

naturally worn (61.4%), device dislodged or dislocated (15.5%), insufficient device problem information (10.2%), implant, removal of (4.9%) and component(s), worn (4.2%). 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 Unknown Depuy Duraloc Liner 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.