Devices › Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Device brand name · Prosthesis hip semi-constrained
OMNI Hip System: medical device reports filed with FDA
269 reports name it, 2015–2026. Manufacturer given most often on reports: Omnilife Science. Product code LPH.
- 269
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 5
- reports, 12 months to August 2026
- 3 in the 12 months before
- 3%
- classified as malfunction
- 7.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
269 medical device reports received by FDA name the brand "OMNI Hip System" (prosthesis hip semi-constrained); the manufacturer given most often on reports is Omnilife Science; received from September 2015 to August 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, up 67% from 3 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%) and malfunction (3%); 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 insufficient device problem information (36.1%), device dislodged or dislocated (6.7%) and fracture (5.9%). The patient problems coded most often are pain, joint dislocation and reaction. 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 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) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 97 | 36.1% | 19.2% |
| Device dislodged or dislocated | 18 | 6.7% | 17% |
| Fracturea broken bone | 16 | 5.9% | 4.4% |
| Metal shedding debris | 8 | 3% | 1.3% |
| Breakthe device broke | 7 | 2.6% | 1.6% |
| Unstable | 7 | 2.6% | 1.1% |
| Loose or intermittent connection | 5 | 1.9% | 1.1% |
| Device slipped | 4 | 1.5% | 0.9% |
| Naturally worn | 4 | 1.5% | 6.1% |
| Nonstandard device | 3 | 1.1% | 0.1% |
| Contamination | 2 | 0.7% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.7% | 0.6% |
| Infusion or flow problema problem with flow or infusion | 2 | 0.7% | 0% |
| Material fragmentation | 2 | 0.7% | 0.1% |
| Packaging problem | 2 | 0.7% | 0.5% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.7% | 0.2% |
| Connection problema connection problem | 1 | 0.4% | 0% |
| Corrodedthe device corroded | 1 | 0.4% | 2.9% |
| Device expiration issue | 1 | 0.4% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0.4% | 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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 62 | 23% |
| Joint dislocationa dislocated joint | 33 | 12.3% |
| Reactiona reaction, type not specified | 13 | 4.8% |
| Bone fracture(s) | 11 | 4.1% |
| Failure of implant | 11 | 4.1% |
| Falla fall | 10 | 3.7% |
| Hip fracturea broken hip | 10 | 3.7% |
| Autoimmune reaction | 4 | 1.5% |
| Metal related pathology | 4 | 1.5% |
| Osteolysis | 4 | 1.5% |
| Toxicity | 4 | 1.5% |
| Joint disorder | 3 | 1.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.7% |
| Joint laxity | 2 | 0.7% |
| Arthritis | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | OMNI Hip System | Product code LPH | All MAUDE reports |
|---|---|---|---|
| Reports | 269 | 90,251 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 97% | 91.7% | 36.2% |
| Classified as malfunction | 3% | 7.5% | 62.3% |
| Filed by the manufacturer | 99.6% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Hip Acetabular Liners | 4,814 | 260 | 0.2% |
| Unknown Hip Acetabular Cup | 3,215 | 106 | 0.4% |
| Apex Hole Elim Positive Stop | 1,082 | 20 | 0.4% |
| Pinn Can Bone Screw 6 5mmx25mm | 1,299 | 32 | 0% |
| Unknown Hip Femoral Stem | 4,140 | 79 | 0.8% |
| Unknown Hip Femoral Head | 5,080 | 176 | 0.7% |
| Pinn Can Bone Screw 6 5mmx20mm | 1,075 | 19 | 0.3% |
| Pinn Can Bone Screw 6 5mmx30mm | 981 | 22 | 0.3% |
| Altrx Neut 36idx52od | 638 | 23 | 0% |
| UNK Hip Femoral Head Ceramic | 720 | 126 | 0.1% |
| Unknown Hip | 2,306 | 5 | 1.9% |
| Trident 0 X3 Insert 36mm Id | 585 | 0 | 0.2% |
| Altrx Neut 36idx54od | 553 | 23 | 0% |
| Altrx Neut 32idx50od | 552 | 21 | 0% |
| Altrx +4 10d 36idx52od | 544 | 17 | 0.2% |
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 OMNI Hip System reports
How many FDA reports name OMNI Hip System?
269 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 (97%) and malfunction (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (36.1%), device dislodged or dislocated (6.7%), fracture (5.9%), metal shedding debris (3%) and break (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and distributor reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that OMNI Hip System 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.