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 28/52: medical device reports filed with FDA
171 reports name it, 2011–2026. Manufacturer given most often on reports: Stryker Orthopaedics-Mahwah. Product code MEH.
- 171
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 5
- reports, 12 months to August 2026
- 3 in the 12 months before
- 2.3%
- classified as malfunction
- 10.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
171 medical device reports received by FDA name the brand "Restoration Adm X3 Ins 28/52" (prosthesis hip semi-constrained uncemented metal/polymer non-porous calicu); the manufacturer given most often on reports is Stryker Orthopaedics-Mahwah; received from March 2011 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
5 reports arrived in the 12 months to August 2026, up 67% from 3 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%) and malfunction (2.3%); 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 device dislodged or dislocated (24.6%), insufficient device problem information (19.3%) and detachment of device or device component (4.1%). 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 |
|---|---|---|---|
| Device dislodged or dislocated | 42 | 24.6% | 7.6% |
| Insufficient device problem information | 33 | 19.3% | 26.3% |
| Detachment of device or device componentpart of the device came off | 7 | 4.1% | 0.6% |
| Unstable | 5 | 2.9% | 1.2% |
| Degraded | 3 | 1.8% | 0.9% |
| Material deformation | 3 | 1.8% | 0.4% |
| Fracturea broken bone | 2 | 1.2% | 3.9% |
| Naturally worn | 2 | 1.2% | 1.6% |
| Detachment of device component | 1 | 0.6% | 0.6% |
| Disassembly | 1 | 0.6% | 0% |
| Loose or intermittent connection | 1 | 0.6% | 2.3% |
| Malposition of device | 1 | 0.6% | 1.3% |
| Migration or expulsion of device | 1 | 0.6% | 0.8% |
| Patient-device incompatibilitythe device did not suit the patient | 1 | 0.6% | 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 |
|---|---|---|
| Injurya physical injury | 48 | 28.1% |
| Joint dislocationa dislocated joint | 25 | 14.6% |
| Painpain, site not specified | 13 | 7.6% |
| Ambulation or postural difficulties | 9 | 5.3% |
| Falla fall | 8 | 4.7% |
| Joint laxity | 4 | 2.3% |
| Bone fracture(s) | 3 | 1.8% |
| Inflammationinflammation | 3 | 1.8% |
| Bacterial infectiona bacterial infection | 2 | 1.2% |
| Discomfortdiscomfort | 2 | 1.2% |
| Fluid discharge | 2 | 1.2% |
| Foreign body reaction | 2 | 1.2% |
| Reactiona reaction, type not specified | 2 | 1.2% |
| Complaint, ill-defined | 1 | 0.6% |
| Dementiadementia | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Restoration Adm X3 Ins 28/52 | Product code MEH | All MAUDE reports |
|---|---|---|---|
| Reports | 171 | 10,210 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 97.7% | 88.9% | 36.2% |
| Classified as malfunction | 2.3% | 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% |
| 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 28/52 reports
How many FDA reports name Restoration Adm X3 Ins 28/52?
171 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
injury (97.7%) and malfunction (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (24.6%), insufficient device problem information (19.3%), detachment of device or device component (4.1%), unstable (2.9%) and degraded (1.8%). 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 28/52 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.