Reported Reactions

Devices › Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer

Device brand name · Prosthesis knee femorotibial semi-constrained cemented metal/polymer

Femoral Head Impactor: medical device reports filed with FDA

185 reports name it, 1998–2026. Manufacturer given most often on reports: Smith & Nephew. Product code HRY.

185
device reports naming the brand
0% of all MAUDE reports · about 7 a year
9
reports, 12 months to August 2026
2 in the 12 months before
91.9%
classified as malfunction
33.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

185 medical device reports received by FDA name the brand "Femoral Head Impactor" (prosthesis knee femorotibial semi-constrained cemented metal/polymer); the manufacturer given most often on reports is Smith & Nephew; received from July 1998 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

9 reports arrived in the 12 months to August 2026, up 350% from 2 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 (91.9%) and injury (8.1%); across all prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer reports (product code HRY) death is recorded in 0.1% and malfunction in 33.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (63.2%), fracture (9.2%) and component missing (3.2%). The patient problems coded most often are no patient involvement, foreign body in patient and injury. 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

0917Sep 2021: 10Oct 2021: 3Nov 2021: 3Dec 2021: 42022Jan 2022: 2Feb 2022: 5Mar 2022: 0Apr 2022: 4May 2022: 17Jun 2022: 4Jul 2022: 8Aug 2022: 3Sep 2022: 4Oct 2022: 3Nov 2022: 1Dec 2022: 02023Jan 2023: 0Feb 2023: 2Mar 2023: 0Apr 2023: 3May 2023: 2Jun 2023: 1Jul 2023: 1Aug 2023: 0Sep 2023: 1Oct 2023: 0Nov 2023: 1Dec 2023: 02024Jan 2024: 1Feb 2024: 1Mar 2024: 0Apr 2024: 2May 2024: 1Jun 2024: 1Jul 2024: 1Aug 2024: 0Sep 2024: 1Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 1Aug 2025: 0Sep 2025: 0Oct 2025: 1Nov 2025: 1Dec 2025: 02026Jan 2026: 1Feb 2026: 2Mar 2026: 2Apr 2026: 1May 2026: 1Jun 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

027541998: 419982019: 1020192020: 3720202021: 5420212022: 5120222023: 1120232024: 820242025: 320252026: 72026

Event type and report source

Event type, as classified on the report

Death0%0
Injury8.1%15
Malfunction91.9%170
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.5%184
Voluntary report0.5%1
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 9,680 reports carrying product code HRY. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke11763.2%17.7%
Fracturea broken bone179.2%9.7%
Component missing63.2%0.4%
Crackthe device cracked42.2%1.6%
Detachment of device or device componentpart of the device came off31.6%2.5%
Material deformation31.6%0.8%
Dull, blunt21.1%0.4%
Material fragmentation10.5%0.6%

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
No patient involvement105.4%
Foreign body in patientpart of a device left in the patient10.5%
Injurya physical injury10.5%

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

In context

MeasureFemoral Head ImpactorProduct code HRYAll MAUDE reports
Reports1859,68026,136,888
Share of that pool—1.9%0%
Classified as death, per 1,000 reports019
Classified as injury8.1%65.5%36.2%
Classified as malfunction91.9%33.2%62.3%
Filed by the manufacturer99.5%97.8%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 HRY

BrandReportsLatest 12 monthsClassified as death
R3 Offset Impactor Tip497440%
Journey Dcf Ap Fem Cut Blk 5169130%
Journey Dcf Ap Fem Cut Blk 6167120%
Unknown Oxford Bearing481420.4%
Enduron 10d 54od X 28id20300%
Foundation Knee System37100%
Enduron 10d 52od X 28id17700%
Enduron 10d 56 Or 68odx28id15920%
Unknown Oxford Tibial Component347320%
Unknown Oxford Femoral Component317300.3%
Specialist 2 Universal Handle29220%
Unknown Depuy Femoral Component47400%
Unknown Knee1,847181.5%
Femoral Implant Impactor700180%
Mbt Cem Keel Tib Tray Sz31,08590%

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 Femoral Head Impactor reports

How many FDA reports name Femoral Head Impactor?

185 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.

What kinds of events are reported?

malfunction (91.9%) and injury (8.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (63.2%), fracture (9.2%), component missing (3.2%), crack (2.2%) and detachment of device or device component (1.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.5%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Femoral Head Impactor 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.