Devices › Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Device brand name · Implant
Abgii Modular Stem: medical device reports filed with FDA
214 reports name it, 2010–2025. Manufacturer given most often on reports: Stryker Orthopaedics-Mahwah. Product code MEH.
- 214
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 1
- reports, 12 months to August 2026
- 4 in the 12 months before
- 1.4%
- classified as malfunction
- 10.5% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
214 medical device reports received by FDA name the brand "Abgii Modular Stem" (implant); the manufacturer given most often on reports is Stryker Orthopaedics-Mahwah; received from June 2010 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1 reports arrived in the 12 months to August 2026, down 75% from 4 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 (97.7%), malfunction (1.4%) and death (0.5%); across all prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate reports (product code MEH) death is recorded in 0.1% and malfunction in 10.5%. 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 (26.2%), device-device incompatibility (7%) and device operates differently than expected (6.5%). The patient problems coded most often are pain, toxicity and hypersensitivity/allergic 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 10,210 reports carrying product code MEH. 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 | 56 | 26.2% | 26.3% |
| Device-device incompatibility | 15 | 7% | 3.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 14 | 6.5% | 3.7% |
| Patient-device incompatibilitythe device did not suit the patient | 10 | 4.7% | 1.1% |
| Metal shedding debris | 8 | 3.7% | 2.1% |
| Fracturea broken bone | 5 | 2.3% | 3.9% |
| Corrodedthe device corroded | 3 | 1.4% | 2% |
| Malposition of device | 2 | 0.9% | 1.3% |
| Contamination | 1 | 0.5% | 0.1% |
| Device appears to trigger rejection | 1 | 0.5% | 0.6% |
| Device contamination with chemical or other material | 1 | 0.5% | 0.5% |
| Device slipped | 1 | 0.5% | 6.8% |
| Failure to osseointegrate | 1 | 0.5% | 0.4% |
| Inadequacy of device shape and/or size | 1 | 0.5% | 0.8% |
| Material erosion | 1 | 0.5% | 0.5% |
| Material integrity problema problem with the device material | 1 | 0.5% | 0.9% |
| Mechanical problema mechanical problem | 1 | 0.5% | 3.3% |
| Moisture or humidity problem | 1 | 0.5% | 0.1% |
| Naturally worn | 1 | 0.5% | 1.6% |
| Noise, audible | 1 | 0.5% | 1.1% |
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 | 60 | 28% |
| Toxicity | 15 | 7% |
| Hypersensitivity/allergic reaction | 14 | 6.5% |
| Reactiona reaction, type not specified | 13 | 6.1% |
| Foreign body reaction | 8 | 3.7% |
| Bone fracture(s) | 7 | 3.3% |
| Inflammationinflammation | 7 | 3.3% |
| Injurya physical injury | 7 | 3.3% |
| Ambulation or postural difficulties | 5 | 2.3% |
| Metal related pathology | 5 | 2.3% |
| Host-tissue reaction | 4 | 1.9% |
| Local reaction | 3 | 1.4% |
| Osteolysis | 3 | 1.4% |
| Chemical exposure | 2 | 0.9% |
| Falla fall | 2 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Abgii Modular Stem | Product code MEH | All MAUDE reports |
|---|---|---|---|
| Reports | 214 | 10,210 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 5 | 1 | 9 |
| Classified as injury | 97.7% | 88.9% | 36.2% |
| Classified as malfunction | 1.4% | 10.5% | 62.3% |
| Filed by the manufacturer | 100% | 97.1% | 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 MEH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Reconstructive Product | 2,579 | 0 | 0.4% |
| Restoration Adm X3 Ins 28/48 | 281 | 6 | 0% |
| Restoration Adm X3 Ins 28/52 | 171 | 5 | 0% |
| Trinity | 673 | 60 | 0.1% |
| Trident Hemispherical Cluster Hole Shell | 210 | 0 | 0% |
| Rejuvenate Strght Prfit Tmzf Mod Stem Size 7 | 172 | 5 | 0% |
| Rejuvenate Strght Prfit Tmzf Mod Stem Size 8 | 156 | 0 | 0% |
| Accolade Plus Tmzf Hip Stem 3 | 263 | 5 | 0% |
| Actis | 217 | 214 | 0% |
| Trident Alumina Insert | 515 | 0 | 0% |
| Accolade Plus Tmzf Hip Stem 4 | 261 | 6 | 0% |
| Unknown Cork Product | 304 | 0 | 0% |
| Unknown Right Hip | 174 | 0 | 0% |
| Anthology Inserter Poster Hard | 192 | 8 | 0% |
| Modular Dual Mobility Insert | 249 | 6 | 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 Abgii Modular Stem reports
How many FDA reports name Abgii Modular Stem?
214 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 (97.7%), malfunction (1.4%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (26.2%), device-device incompatibility (7%), device operates differently than expected (6.5%), patient-device incompatibility (4.7%) and metal shedding debris (3.7%). 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 Abgii Modular Stem 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.