Reported Reactions

Devices › Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Device brand name · Hip resurfacing prosthesis

Cormet: medical device reports filed with FDA

161 reports name it, 2012–2024. Manufacturer given most often on reports: Corin Medical. Product code NXT.

161
device reports naming the brand
0% of all MAUDE reports · about 12 a year
0
reports, 12 months to August 2026
0 in the 12 months before
1.9%
classified as malfunction
1.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 161 reports that name the brand "Cormet" (hip resurfacing prosthesis), received between July 2012 and August 2024; the manufacturer given most often on reports is Corin Medical. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (88.2%) and malfunction (1.9%); across all prosthesis, hip, semi-constrained, metal/metal, resurfacing reports (product code NXT) death is recorded in 0.3% and malfunction in 1.7%. 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 (16.8%), metal shedding debris (3.7%) and degraded (3.1%). The patient problems coded most often are pain, toxicity and 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

012Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 1Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 2Nov 2023: 1Dec 2023: 02024Jan 2024: 1Feb 2024: 0Mar 2024: 1Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 1Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

032632012: 1720122014: 620142015: 1120152016: 6320162017: 1820172018: 1920182019: 1420192020: 620202023: 420232024: 32024

Event type and report source

Event type, as classified on the report

Death0%0
Injury88.2%142
Malfunction1.9%3
Other0%0
Not given9.9%16

Who filed the report

Manufacturer report98.8%159
Voluntary report0.6%1
User facility report0%0
Distributor report0%0
Not given0.6%1

Grey bar: all 6,888 reports carrying product code NXT. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Insufficient device problem information2716.8%35.4%
Metal shedding debris63.7%4.4%
Degraded53.1%0.3%
Loose or intermittent connection53.1%1.4%
Patient-device incompatibilitythe device did not suit the patient53.1%3%
Device slipped42.5%2.5%
Material fragmentation21.2%0.6%
Breakthe device broke10.6%1.5%
Contamination /decontamination problem10.6%0%
Crackthe device cracked10.6%0.1%
Detachment of device component10.6%0.1%
Device operates differently than expectedthe device behaved unexpectedly10.6%3.4%
Fracturea broken bone10.6%2.3%
Material integrity problema problem with the device material10.6%1%
Material protrusion/extrusion10.6%0%
Mechanical problema mechanical problem10.6%0.6%
Migration or expulsion of device10.6%0.2%
Noise, audible10.6%1.5%

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)ReportsShare
Painpain, site not specified3119.3%
Toxicity2716.8%
Reactiona reaction, type not specified74.3%
Test result63.7%
Metal related pathology53.1%
Failure of implant31.9%
Osteolysis31.9%
Cyst(s)21.2%
Hematomaa collection of blood under the skin or in tissue21.2%
Complaint, ill-defined10.6%
Fluid discharge10.6%
Granuloma10.6%
High blood pressure/ hypertension10.6%
Loss of range of motion10.6%
No patient involvement10.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureCormetProduct code NXTAll MAUDE reports
Reports1616,88826,136,888
Share of that pool—2.3%0%
Classified as death, per 1,000 reports039
Classified as injury88.2%95.5%36.2%
Classified as malfunction1.9%1.7%62.3%
Filed by the manufacturer98.8%98.6%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 NXT

BrandReportsLatest 12 monthsClassified as death
Bhr2,27500%
R342400.2%
Unkn Birmingham Hip Resurfacing Bhr Cup Unkn Type22700.9%
Acetlr Cup Hap 56mm W/ Imptr18110.6%
Acetlr Cup Hap 52mm W/ Imptr16700%
Cormet Resurfacing16200%
Bhr Acetabular Cup15000%
Conserve R Plus Cup1,32800%
Asr Acetabular Implant 6042600.7%
Trinity673600.1%
Unknown Hip Implant1,11490.6%
Total Asr Fem Imp Size 4653400%

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 Cormet reports

How many FDA reports name Cormet?

161 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (88.2%) and malfunction (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (16.8%), metal shedding debris (3.7%), degraded (3.1%), loose or intermittent connection (3.1%) and patient-device incompatibility (3.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.8%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Cormet 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.