Devices › Prosthesis, hip, semi-constrained, metal/polymer, cemented
Device brand name · Articuleze head 12/14 taper hip metal femoral heads
12/14 Articul 40mm M Spec-2: medical device reports filed with FDA
377 reports name it, 2009–2025. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code JDI.
- 377
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 1
- reports, 12 months to August 2026
- 5 in the 12 months before
- 2.9%
- classified as malfunction
- 7.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 377 reports that name the brand "12/14 Articul 40mm M Spec-2" (articuleze head 12/14 taper hip metal femoral heads), received between February 2009 and November 2025; the manufacturer given most often on reports is Depuy Orthopaedics US. Spellings of one product vary from report to report.
1 reports arrived in the 12 months to August 2026, down 80% from 5 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 (97.1%) and malfunction (2.9%); across all prosthesis, hip, semi-constrained, metal/polymer, cemented reports (product code JDI) death is recorded in 0.4% and malfunction in 7.8%. 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 (57.3%), naturally worn (30.2%) and metal shedding debris (11.9%). The patient problems coded most often are pain, discomfort and inflammation. 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 70,618 reports carrying product code JDI. 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 | 216 | 57.3% | 30.7% |
| Naturally worn | 114 | 30.2% | 11.7% |
| Metal shedding debris | 45 | 11.9% | 3.5% |
| Device dislodged or dislocated | 41 | 10.9% | 14.7% |
| Material disintegration | 27 | 7.2% | 2% |
| Noise, audible | 23 | 6.1% | 2.4% |
| Corrodedthe device corroded | 18 | 4.8% | 2.9% |
| Degraded | 4 | 1.1% | 1.4% |
| Loss of or failure to bond | 4 | 1.1% | 1.2% |
| Loss of osseointegration | 3 | 0.8% | 2.1% |
| Biocompatibility | 2 | 0.5% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.3% | 1.2% |
| Fracturea broken bone | 1 | 0.3% | 3.7% |
| Inadequacy of device shape and/or size | 1 | 0.3% | 0.3% |
| Malposition of device | 1 | 0.3% | 1% |
| Material erosion | 1 | 0.3% | 1.1% |
| Packaging problem | 1 | 0.3% | 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 | 268 | 71.1% |
| Discomfortdiscomfort | 135 | 35.8% |
| Inflammationinflammation | 75 | 19.9% |
| Foreign body reaction | 74 | 19.6% |
| Host-tissue reaction | 58 | 15.4% |
| Tissue damage | 35 | 9.3% |
| Limited mobility of the implanted joint | 23 | 6.1% |
| Joint dislocationa dislocated joint | 22 | 5.8% |
| Ambulation or postural difficulties | 16 | 4.2% |
| Test result | 16 | 4.2% |
| Not applicable | 15 | 4% |
| Osteolysis | 12 | 3.2% |
| Hypersensitivity/allergic reaction | 10 | 2.7% |
| Injurya physical injury | 10 | 2.7% |
| Loss of range of motion | 7 | 1.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 12/14 Articul 40mm M Spec-2 | Product code JDI | All MAUDE reports |
|---|---|---|---|
| Reports | 377 | 70,618 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 97.1% | 91.3% | 36.2% |
| Classified as malfunction | 2.9% | 7.8% | 62.3% |
| Filed by the manufacturer | 100% | 98.4% | 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 JDI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Articuleze M Head 36mm +1 5 | 3,431 | 24 | 0.1% |
| Articuleze M Head 36mm +5 | 3,111 | 24 | 0.1% |
| Unknown Hip Femoral Head | 5,080 | 176 | 0.7% |
| Articuleze M Head 36mm -2 | 1,661 | 10 | 0.2% |
| Articuleze M Head 36mm +8 5 | 1,674 | 11 | 0.1% |
| Unknown Hip Femoral Stem | 4,140 | 79 | 0.8% |
| Unknown Hip | 2,306 | 5 | 1.9% |
| Unknown Head | 2,250 | 103 | 0.7% |
| Unknown Stem | 1,857 | 84 | 0.5% |
| Unknown liner | 2,255 | 75 | 0.4% |
| Unknown Reconstructive Product | 2,579 | 0 | 0.4% |
| Articul/Eze Ball 32 +1 Gr | 695 | 5 | 0.1% |
| UNK Hip Femoral Head Metal | 728 | 67 | 0.1% |
| Articul/Eze Ball 28 +1 5 Gr | 641 | 20 | 0.3% |
| S-Rom M Head 36mm +0 | 827 | 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 12/14 Articul 40mm M Spec-2 reports
How many FDA reports name 12/14 Articul 40mm M Spec-2?
377 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
injury (97.1%) and malfunction (2.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (57.3%), naturally worn (30.2%), metal shedding debris (11.9%), device dislodged or dislocated (10.9%) and material disintegration (7.2%). 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 12/14 Articul 40mm M Spec-2 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.