Devices › Prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Device brand name · Hip femoral stem/sleeve
Corail2 Std Size 11: medical device reports filed with FDA
566 reports name it, 2005–2025. Manufacturer given most often on reports: Depuy France Sas - 3003895575. Product code KWA.
- 566
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 2
- reports, 12 months to August 2026
- 8 in the 12 months before
- 3.2%
- classified as malfunction
- 3.4% across the product code
- 0.5%
- classified as death, as reported
- 3 reports · not verified by FDA
566 medical device reports received by FDA name the brand "Corail2 Std Size 11" (hip femoral stem/sleeve); the manufacturer given most often on reports is Depuy France Sas - 3003895575; received from April 2005 to December 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
2 reports arrived in the 12 months to August 2026, down 75% from 8 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 (96.3%), malfunction (3.2%) and death (0.5%); across all prosthesis, hip, semi-constrained (metal uncemented acetabular component) reports (product code KWA) death is recorded in 0.3% and malfunction in 3.4%. 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 (40.6%), loss of osseointegration (14.5%) and corroded (3.7%). The patient problems coded most often are pain, test result and foreign body 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 138,213 reports carrying product code KWA. 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 | 230 | 40.6% | 52% |
| Loss of osseointegration | 82 | 14.5% | 5.1% |
| Corrodedthe device corroded | 21 | 3.7% | 2% |
| Osseointegration problem | 14 | 2.5% | 0.8% |
| Degraded | 12 | 2.1% | 0.3% |
| Biocompatibility | 10 | 1.8% | 0.3% |
| Loss of or failure to bond | 10 | 1.8% | 1.2% |
| Migration or expulsion of device | 10 | 1.8% | 1% |
| Metal shedding debris | 8 | 1.4% | 7.6% |
| Fracturea broken bone | 7 | 1.2% | 1.3% |
| Naturally worn | 7 | 1.2% | 6.7% |
| Loose or intermittent connection | 5 | 0.9% | 1.2% |
| Noise, audible | 5 | 0.9% | 3.2% |
| Inadequacy of device shape and/or size | 4 | 0.7% | 0.2% |
| Malposition of device | 4 | 0.7% | 1.4% |
| Fitting problem | 3 | 0.5% | 0.1% |
| Material disintegration | 3 | 0.5% | 1.3% |
| Breakthe device broke | 2 | 0.4% | 0.5% |
| Loosening of implant not related to bone-ingrowth | 2 | 0.4% | 0.2% |
| Migrationthe device moved from where it was placed | 2 | 0.4% | 0.4% |
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 | 299 | 52.8% |
| Test result | 52 | 9.2% |
| Foreign body reaction | 51 | 9% |
| Discomfortdiscomfort | 43 | 7.6% |
| Tissue damage | 41 | 7.2% |
| Host-tissue reaction | 36 | 6.4% |
| Inadequate osseointegration | 36 | 6.4% |
| Limited mobility of the implanted joint | 24 | 4.2% |
| Inflammationinflammation | 23 | 4.1% |
| Bone fracture(s) | 22 | 3.9% |
| Osteolysis | 20 | 3.5% |
| Not applicable | 18 | 3.2% |
| Injurya physical injury | 13 | 2.3% |
| Falla fall | 9 | 1.6% |
| Ambulation or postural difficulties | 8 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Corail2 Std Size 11 | Product code KWA | All MAUDE reports |
|---|---|---|---|
| Reports | 566 | 138,213 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 5 | 3 | 9 |
| Classified as injury | 96.3% | 94.3% | 36.2% |
| Classified as malfunction | 3.2% | 3.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.2% | 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 KWA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pinnacle Mtl Ins Neut36idx52od | 3,720 | 13 | 0.1% |
| Pinnacle Mtl Ins Neut36idx54od | 2,874 | 11 | 0.1% |
| Asr Acetabular Cups 52 | 2,428 | 2 | 0.1% |
| Asr Uni Femoral Impl Size 46 | 2,500 | 2 | 0.1% |
| Asr Acetabular Cups 54 | 2,350 | 0 | 0.4% |
| Asr Uni Femoral Impl Size 47 | 2,423 | 0 | 0.4% |
| Asr Acetabular Cups 56 | 2,206 | 0 | 0.4% |
| Asr Uni Femoral Impl Size 49 | 2,278 | 0 | 0.4% |
| Asr Acetabular Cups 50 | 2,056 | 0 | 0.1% |
| Asr Uni Femoral Impl Size 45 | 2,119 | 0 | 0.1% |
| Pinnacle Mtl Ins Neut36idx50od | 2,066 | 9 | 0% |
| Unknown Hip Acetabular Liners | 4,814 | 260 | 0.2% |
| Durom Acetabular Component | 2,071 | 0 | 0.1% |
| Unknown Hip Acetabular Cup | 3,215 | 106 | 0.4% |
| Unknown Depuy Asr Acetabular Cup | 1,933 | 0 | 0.2% |
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 Corail2 Std Size 11 reports
How many FDA reports name Corail2 Std Size 11?
566 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
injury (96.3%), malfunction (3.2%) 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 (40.6%), loss of osseointegration (14.5%), corroded (3.7%), osseointegration problem (2.5%) and degraded (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 Corail2 Std Size 11 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.