Devices › Device types
FDA product code MEH · class 2 · Orthopedic
Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate: medical device reports filed with FDA
10,210 reports carry this product code, 1997–2026; 30 brands with a page.
- 10,210
- reports with this product code
- 0% of all MAUDE reports
- 385
- reports, 12 months to August 2026
- 460 in the 12 months before
- 10.5%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code MEH is FDA's classification for "Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate" (orthopedic panel), a class 2 device. 10,210 medical device reports carry this product code, 0% of the MAUDE database, from July 1997 to August 2026.
385 reports arrived in the 12 months to August 2026, down 16% from 460 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 (88.9%), malfunction (10.5%) and other (0.3%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Stryker Orthopaedics-Mahwah | 3,447 | 33.8% |
| Stryker Orthopaedics Cork | 2,278 | 22.3% |
| Stryker Orthopaedics Mahwah | 1,004 | 9.8% |
| Medacta International | 661 | 6.5% |
| Exactech | 118 | 1.2% |
| Stryker | 75 | 0.7% |
| Depuy France | 63 | 0.6% |
| Howmedica Osteonics | 25 | 0.2% |
| Depuy France Sas - 3003895575 | 16 | 0.2% |
| Limacorporate | 15 | 0.1% |
| Depuy France Sas 3003895575 | 12 | 0.1% |
| Howmedica | 12 | 0.1% |
| Biomet UK | 8 | 0.1% |
| Depuy International 8010379 | 6 | 0.1% |
| Depuy International | 5 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Insufficient device problem information | 2,682 | 26.3% |
| Device dislodged or dislocated | 776 | 7.6% |
| Device slipped | 696 | 6.8% |
| Device-device incompatibility | 395 | 3.9% |
| Fracturea broken bone | 395 | 3.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 375 | 3.7% |
| Nonstandard device | 363 | 3.6% |
| Breakthe device broke | 359 | 3.5% |
| Mechanical problema mechanical problem | 332 | 3.3% |
| Explanted | 324 | 3.2% |
| Loose or intermittent connection | 237 | 2.3% |
| Metal shedding debris | 219 | 2.1% |
| Corrodedthe device corroded | 203 | 2% |
| Loose | 178 | 1.7% |
| Osseointegration problem | 165 | 1.6% |
| Naturally worn | 163 | 1.6% |
| Replace | 152 | 1.5% |
| Malposition of device | 132 | 1.3% |
| Unstable | 119 | 1.2% |
| Patient-device incompatibilitythe device did not suit the patient | 115 | 1.1% |
Questions about prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate reports
What is product code MEH?
FDA's classification code for "Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
10,210 reports through August 2026, 385 of them in the latest 12 months.
Which brands appear most often?
Unknown Reconstructive Product (479), Restoration Adm X3 Ins 28/48 (246), Restoration Adm X3 Ins 28/52 (149), Abgii Modular Stem (139) and Trinity (133). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.