Devices › Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Device brand name · Articuleze head 12/14 taper hip ceramic femoral heads
BIOLOX Delta: medical device reports filed with FDA
369 reports name it, 2017–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code LZO.
- 369
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 255
- reports, 12 months to August 2026
- 35 in the 12 months before
- 1.9%
- classified as malfunction
- 9.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 369 reports that name the brand "BIOLOX Delta" (articuleze head 12/14 taper hip ceramic femoral heads), received between September 2017 and August 2026; the manufacturer given most often on reports is Depuy Orthopaedics US. Spellings of one product vary from report to report.
255 reports arrived in the 12 months to August 2026, up 629% from 35 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 (98.1%) and malfunction (1.9%); across all prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented reports (product code LZO) death is recorded in 0.2% and malfunction in 9.1%. 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 (24.4%), insufficient device problem information (14.6%) and naturally worn (2.2%). The patient problems coded most often are joint dislocation, joint laxity 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
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 32,865 reports carrying product code LZO. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 90 | 24.4% | 18.4% |
| Insufficient device problem information | 54 | 14.6% | 18.4% |
| Naturally worn | 8 | 2.2% | 2.4% |
| Fracturea broken bone | 7 | 1.9% | 6.9% |
| Noise, audible | 6 | 1.6% | 1.3% |
| Improper or incorrect procedure or method | 2 | 0.5% | 0.3% |
| Patient device interaction problem | 2 | 0.5% | 0.4% |
| Wrong label | 2 | 0.5% | 0.1% |
| Defective component | 1 | 0.3% | 0% |
| Device contaminated during manufacture or shipping | 1 | 0.3% | 0.2% |
| Difficult to insertthe device was hard to insert | 1 | 0.3% | 0.7% |
| Difficult to removethe device was hard to remove | 1 | 0.3% | 0.2% |
| Failure to align | 1 | 0.3% | 0% |
| Loss of osseointegration | 1 | 0.3% | 1% |
| Material integrity problema problem with the device material | 1 | 0.3% | 0.3% |
| Migration or expulsion of device | 1 | 0.3% | 0.8% |
| Physical resistance/sticking | 1 | 0.3% | 0% |
| Tear, rip or hole in device packaging | 1 | 0.3% | 0.9% |
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 |
|---|---|---|
| Joint dislocationa dislocated joint | 126 | 34.1% |
| Joint laxity | 49 | 13.3% |
| Painpain, site not specified | 32 | 8.7% |
| Falla fall | 12 | 3.3% |
| Bone fracture(s) | 9 | 2.4% |
| Physical asymmetry | 9 | 2.4% |
| Unequal limb length | 5 | 1.4% |
| Hematomaa collection of blood under the skin or in tissue | 4 | 1.1% |
| Ambulation or postural difficulties | 3 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.8% |
| Bone notching | 3 | 0.8% |
| Discomfortdiscomfort | 3 | 0.8% |
| Fluid discharge | 3 | 0.8% |
| Foreign body reaction | 3 | 0.8% |
| Medical device site infectioninfection at the device site | 3 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | BIOLOX Delta | Product code LZO | All MAUDE reports |
|---|---|---|---|
| Reports | 369 | 32,865 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 98.1% | 89.9% | 36.2% |
| Classified as malfunction | 1.9% | 9.1% | 62.3% |
| Filed by the manufacturer | 99.5% | 98.3% | 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 LZO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Delta Cer Head 12/14 36mm +1 5 | 1,191 | 59 | 0% |
| Delta Cer Head 12/14 36mm +5 | 914 | 47 | 0% |
| Delta Cer Head 12/14 32mm +1 | 789 | 39 | 0% |
| Biolox Delta Hip | 549 | 0 | 0% |
| Delta Cer Head 12/14 32mm +5 | 439 | 12 | 0.2% |
| Unknown Head | 2,250 | 103 | 0.7% |
| Delta Cer Head 12/14 36mm +8 5 | 362 | 22 | 0% |
| UNK Hip Femoral Stem Corail | 523 | 56 | 0.8% |
| Trinity | 673 | 60 | 0.1% |
| Dlt Ts Cer Hd 12/14 36mm +1 5 | 310 | 2 | 0% |
| Mectacer Biolox Delta Femoral Ball Head | 224 | 116 | 0% |
| Modular Dual Mobility Insert | 249 | 6 | 0% |
| Delta Cer Head 12/14 28mm +1 5 | 232 | 13 | 0% |
| Dlt Ts Cer Hd 12/14 36mm +5 0 | 296 | 7 | 0.3% |
| Unknown Stem | 1,857 | 84 | 0.5% |
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 BIOLOX Delta reports
How many FDA reports name BIOLOX Delta?
369 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 255 in the latest 12 months.
What kinds of events are reported?
injury (98.1%) and malfunction (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (24.4%), insufficient device problem information (14.6%), naturally worn (2.2%), fracture (1.9%) and noise, audible (1.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that BIOLOX Delta 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.