Devices › Prosthesis, hip, semi-constrained, metal/polymer, uncemented
Device brand name · Hip component
PROFEMUR Modular Femoral Neck: medical device reports filed with FDA
585 reports name it, 2005–2026. Manufacturer given most often on reports: Microport Orthopedics. Product code LWJ.
- 585
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 29
- reports, 12 months to August 2026
- 17 in the 12 months before
- 1.9%
- classified as malfunction
- 8% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 585 reports that name the brand "PROFEMUR Modular Femoral Neck" (hip component), received between April 2005 and August 2026; the manufacturer given most often on reports is Microport Orthopedics. Spellings of one product vary from report to report.
29 reports arrived in the 12 months to August 2026, up 71% from 17 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 (97.3%), malfunction (1.9%) and death (0.2%); across all prosthesis, hip, semi-constrained, metal/polymer, uncemented reports (product code LWJ) death is recorded in 0.3% and malfunction in 8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (28%), insufficient device problem information (16.4%) and device dislodged or dislocated (14.9%). The patient problems coded most often are pain, metal related pathology and failure of implant. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 4,172 reports carrying product code LWJ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 164 | 28% | 21% |
| Insufficient device problem information | 96 | 16.4% | 19.9% |
| Device dislodged or dislocated | 87 | 14.9% | 6.5% |
| Component(s), broken | 68 | 11.6% | 1.7% |
| Corrodedthe device corroded | 35 | 6% | 3.3% |
| Loose or intermittent connection | 10 | 1.7% | 2.9% |
| Naturally worn | 9 | 1.5% | 1.4% |
| Detachment of device or device componentpart of the device came off | 7 | 1.2% | 0.4% |
| Difficult to removethe device was hard to remove | 6 | 1% | 0.4% |
| Explanted | 6 | 1% | 5.3% |
| Fracturea broken bone | 6 | 1% | 7.7% |
| Loose | 5 | 0.9% | 1.3% |
| Mechanical problema mechanical problem | 4 | 0.7% | 0.3% |
| Noise, audible | 4 | 0.7% | 0.6% |
| Dislocated | 3 | 0.5% | 0.7% |
| Loosening of implant not related to bone-ingrowth | 2 | 0.3% | 0.1% |
| Material disintegration | 2 | 0.3% | 0.2% |
| Replace | 2 | 0.3% | 1.8% |
| Unstable | 2 | 0.3% | 0.6% |
| Coagulation in device or device ingredient | 1 | 0.2% | 0% |
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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 52 | 8.9% |
| Metal related pathology | 20 | 3.4% |
| Failure of implant | 12 | 2.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 11 | 1.9% |
| Loss of range of motion | 8 | 1.4% |
| Bone fracture(s) | 7 | 1.2% |
| Osteolysis | 6 | 1% |
| Hospitalization required | 5 | 0.9% |
| Reactiona reaction, type not specified | 5 | 0.9% |
| Falla fall | 4 | 0.7% |
| Hypersensitivity/allergic reaction | 4 | 0.7% |
| Surgical procedure | 4 | 0.7% |
| Unequal limb length | 4 | 0.7% |
| Joint dislocationa dislocated joint | 3 | 0.5% |
| Discomfortdiscomfort | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | PROFEMUR Modular Femoral Neck | Product code LWJ | All MAUDE reports |
|---|---|---|---|
| Reports | 585 | 4,172 | 26,136,888 |
| Share of that pool | — | 14% | 0% |
| Classified as death, per 1,000 reports | 2 | 3 | 9 |
| Classified as injury | 97.3% | 90.7% | 36.2% |
| Classified as malfunction | 1.9% | 8% | 62.3% |
| Filed by the manufacturer | 99.8% | 98% | 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 LWJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Profemur R Modular Femoral Neck | 1,756 | 0 | 0.1% |
| Trinity | 673 | 60 | 0.1% |
| Profemur R Cocr Neck | 472 | 0 | 0.2% |
| Srom Stm St 36+8l Nk 18x13x160 | 660 | 1 | 0% |
| OMNI Hip System | 269 | 5 | 0% |
| Srom Stm St 36+8l Nk 20x15x165 | 218 | 0 | 0.9% |
| Femoral Head | 303 | 11 | 0% |
| V40 Cocr Lfit Head 36mm/+5 | 524 | 0 | 0.2% |
| V40 Cocr Lfit Head 36mm/0 | 268 | 0 | 0% |
| Head | 278 | 0 | 0% |
| Novation | 235 | 23 | 0.4% |
| Summit Por Taper Sz5 Std Off | 472 | 1 | 0.2% |
| Summit Por Taper Sz7 Std Off | 291 | 3 | 0% |
| Bhr | 2,275 | 0 | 0% |
| Conserve R Total Head W/Bfh | 465 | 0 | 0% |
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 PROFEMUR Modular Femoral Neck reports
How many FDA reports name PROFEMUR Modular Femoral Neck?
585 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 29 in the latest 12 months.
What kinds of events are reported?
injury (97.3%), malfunction (1.9%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (28%), insufficient device problem information (16.4%), device dislodged or dislocated (14.9%), component(s), broken (11.6%) and corroded (6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that PROFEMUR Modular Femoral Neck 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.