Device brand name · Hip instruments insertion devices
Retaining Stem Inserter: medical device reports filed with FDA
627 reports name it, 2014–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code HWR.
- 627
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 41
- reports, 12 months to August 2026
- 51 in the 12 months before
- 98.9%
- classified as malfunction
- 97.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 627 reports that name the brand "Retaining Stem Inserter" (hip instruments insertion devices), received between January 2014 and August 2026; the manufacturer given most often on reports is Depuy Orthopaedics US. Spellings of one product vary from report to report.
41 reports arrived in the 12 months to August 2026, down 20% from 51 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 malfunction (98.9%) and injury (1.1%); across all driver, prosthesis reports (product code HWR) death is recorded in 0% and malfunction in 97.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (37.6%), naturally worn (21.2%) and device-device incompatibility (21.1%). The patient problems coded most often are not applicable, foreign body in patient and device embedded in tissue or plaque. 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 9,800 reports carrying product code HWR. 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 |
|---|---|---|---|
| Breakthe device broke | 236 | 37.6% | 51.1% |
| Naturally worn | 133 | 21.2% | 4.3% |
| Device-device incompatibility | 132 | 21.1% | 10.2% |
| Material deformation | 96 | 15.3% | 8.7% |
| Material twisted/bent | 91 | 14.5% | 22.1% |
| Scratched material | 16 | 2.6% | 0.4% |
| Entrapment of device | 15 | 2.4% | 1.4% |
| Bent | 12 | 1.9% | 0.2% |
| Mechanical jam | 9 | 1.4% | 1.1% |
| Material integrity problema problem with the device material | 8 | 1.3% | 0.9% |
| Connection problema connection problem | 7 | 1.1% | 0.2% |
| Corrodedthe device corroded | 5 | 0.8% | 0.1% |
| Insufficient device problem information | 5 | 0.8% | 0.1% |
| Physical resistance/sticking | 5 | 0.8% | 0.3% |
| Contamination /decontamination problem | 3 | 0.5% | 0.4% |
| Crackthe device cracked | 3 | 0.5% | 3.3% |
| Component incompatible | 1 | 0.2% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.2% | 0% |
| Device slipped | 1 | 0.2% | 0.9% |
| Difficult to insertthe device was hard to insert | 1 | 0.2% | 0.1% |
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 |
|---|---|---|
| Not applicable | 21 | 3.3% |
| Foreign body in patientpart of a device left in the patient | 7 | 1.1% |
| Device embedded in tissue or plaque | 2 | 0.3% |
| No patient involvement | 2 | 0.3% |
| Limb fracture | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Retaining Stem Inserter | Product code HWR | All MAUDE reports |
|---|---|---|---|
| Reports | 627 | 9,800 | 26,136,888 |
| Share of that pool | — | 6.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 1.1% | 2.4% | 36.2% |
| Classified as malfunction | 98.9% | 97.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.9% | 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 HWR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Attune Femoral Introducer | 1,497 | 202 | 0% |
| Angled Acet Insertr | 1,090 | 59 | 0% |
| Cor/Tri Ant Stem Insert Shaft | 1,207 | 50 | 0% |
| Verse X25 Inserter/Tightener | 686 | 87 | 0% |
| X25 Final Tightener | 477 | 15 | 0% |
| Summit Standard Imp Inserter | 281 | 15 | 0% |
| Viper2 Final Tightener Driver | 223 | 22 | 0% |
| Driver | 214 | 27 | 0% |
| Star Driver 20 | 186 | 57 | 0% |
| Mmsi Final Tightener | 185 | 0 | 0% |
| Moss Miami Spine System Hexlobe Driver 5 5 X25 | 175 | 0 | 0% |
| Expedium Verse Spine System Inserter/Tightener X25 | 174 | 2 | 0% |
| Expedium Verse | 178 | 127 | 0% |
| Symphony | 1,163 | 133 | 1.6% |
| Xpdm Quick-Con Si Poly Scwdrvr | 446 | 13 | 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 Retaining Stem Inserter reports
How many FDA reports name Retaining Stem Inserter?
627 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 41 in the latest 12 months.
What kinds of events are reported?
malfunction (98.9%) and injury (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (37.6%), naturally worn (21.2%), device-device incompatibility (21.1%), material deformation (15.3%) and material twisted/bent (14.5%). 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 Retaining Stem Inserter 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.