Devices › Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Device brand name · Prosthesis hip semi-constrained uncemented metal/polymer non-porous calicu
Restoration Adm X3 Ins 28/48: medical device reports filed with FDA
281 reports name it, 2011–2026. Manufacturer given most often on reports: Stryker Orthopaedics-Mahwah. Product code MEH.
- 281
- device reports naming the brand
- 0% of all MAUDE reports · about 19 a year
- 6
- reports, 12 months to August 2026
- 13 in the 12 months before
- 2.1%
- classified as malfunction
- 10.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 281 reports that name the brand "Restoration Adm X3 Ins 28/48" (prosthesis hip semi-constrained uncemented metal/polymer non-porous calicu), received between July 2011 and August 2026; the manufacturer given most often on reports is Stryker Orthopaedics-Mahwah. Spellings of one product vary from report to report.
6 reports arrived in the 12 months to August 2026, down 54% from 13 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 (97.5%), malfunction (2.1%) and other (0.4%); 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 (35.6%), device dislodged or dislocated (33.8%) and detachment of device or device component (6%). The patient problems coded most often are injury, joint dislocation 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 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 | 100 | 35.6% | 26.3% |
| Device dislodged or dislocated | 95 | 33.8% | 7.6% |
| Detachment of device or device componentpart of the device came off | 17 | 6% | 0.6% |
| Mechanical problema mechanical problem | 6 | 2.1% | 3.3% |
| Unstable | 6 | 2.1% | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 1.4% | 3.7% |
| Material deformation | 4 | 1.4% | 0.4% |
| Scratched material | 4 | 1.4% | 0.1% |
| Degraded | 3 | 1.1% | 0.9% |
| Detachment of device component | 3 | 1.1% | 0.6% |
| Device slipped | 3 | 1.1% | 6.8% |
| Fracturea broken bone | 3 | 1.1% | 3.9% |
| Material separation | 2 | 0.7% | 0.4% |
| Naturally worn | 2 | 0.7% | 1.6% |
| Noise, audible | 2 | 0.7% | 1.1% |
| Breakthe device broke | 1 | 0.4% | 3.5% |
| Defective component | 1 | 0.4% | 0.1% |
| Device contamination with chemical or other material | 1 | 0.4% | 0.5% |
| Extrusion | 1 | 0.4% | 0% |
| Human-device interface problem | 1 | 0.4% | 0% |
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 |
|---|---|---|
| Injurya physical injury | 98 | 34.9% |
| Joint dislocationa dislocated joint | 72 | 25.6% |
| Painpain, site not specified | 29 | 10.3% |
| Ambulation or postural difficulties | 23 | 8.2% |
| Bone fracture(s) | 8 | 2.8% |
| Falla fall | 8 | 2.8% |
| Loss of range of motion | 4 | 1.4% |
| Abscessa collection of pus | 2 | 0.7% |
| Joint laxity | 2 | 0.7% |
| Osteolysis | 2 | 0.7% |
| Scar tissue | 2 | 0.7% |
| Bacterial infectiona bacterial infection | 1 | 0.4% |
| Cancer | 1 | 0.4% |
| Cognitive changes | 1 | 0.4% |
| Discomfortdiscomfort | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Restoration Adm X3 Ins 28/48 | Product code MEH | All MAUDE reports |
|---|---|---|---|
| Reports | 281 | 10,210 | 26,136,888 |
| Share of that pool | — | 2.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 97.5% | 88.9% | 36.2% |
| Classified as malfunction | 2.1% | 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 28/52 | 171 | 5 | 0% |
| Abgii Modular Stem | 214 | 1 | 0.5% |
| 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 Restoration Adm X3 Ins 28/48 reports
How many FDA reports name Restoration Adm X3 Ins 28/48?
281 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.
What kinds of events are reported?
injury (97.5%), malfunction (2.1%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (35.6%), device dislodged or dislocated (33.8%), detachment of device or device component (6%), mechanical problem (2.1%) and unstable (2.1%). 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 Restoration Adm X3 Ins 28/48 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.