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Device brand name · Attune instruments impactors

Attune Femoral Impactor: medical device reports filed with FDA

3,328 reports name it, 2015–2026. Manufacturer given most often on reports: Depuy Ireland - 9616671. Product code HWA.

3,328
device reports naming the brand
0% of all MAUDE reports · about 292 a year
121
reports, 12 months to August 2026
234 in the 12 months before
99.5%
classified as malfunction
98% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 3,328 reports that name the brand "Attune Femoral Impactor" (attune instruments impactors), received between February 2015 and June 2026; the manufacturer given most often on reports is Depuy Ireland - 9616671. Spellings of one product vary from report to report.

121 reports arrived in the 12 months to August 2026, down 48% from 234 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 (99.5%) and injury (0.5%); across all impactor reports (product code HWA) death is recorded in 0% and malfunction in 98%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (89.1%), crack (16.3%) and naturally worn (1.7%). The patient problems coded most often are not applicable, no patient involvement and foreign body in patient. 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

02141Sep 2021: 34Oct 2021: 27Nov 2021: 31Dec 2021: 412022Jan 2022: 28Feb 2022: 18Mar 2022: 26Apr 2022: 21May 2022: 26Jun 2022: 20Jul 2022: 22Aug 2022: 25Sep 2022: 26Oct 2022: 18Nov 2022: 34Dec 2022: 382023Jan 2023: 36Feb 2023: 27Mar 2023: 29Apr 2023: 27May 2023: 34Jun 2023: 23Jul 2023: 17Aug 2023: 17Sep 2023: 14Oct 2023: 25Nov 2023: 38Dec 2023: 192024Jan 2024: 27Feb 2024: 27Mar 2024: 21Apr 2024: 21May 2024: 16Jun 2024: 19Jul 2024: 27Aug 2024: 17Sep 2024: 23Oct 2024: 25Nov 2024: 19Dec 2024: 182025Jan 2025: 14Feb 2025: 13Mar 2025: 16Apr 2025: 22May 2025: 18Jun 2025: 21Jul 2025: 24Aug 2025: 21Sep 2025: 14Oct 2025: 18Nov 2025: 18Dec 2025: 212026Jan 2026: 17Feb 2026: 15Mar 2026: 13Apr 2026: 4May 2026: 0Jun 2026: 1Jul 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

01903792015: 24120152016: 3792017: 29120172018: 3082019: 32620192020: 2852021: 36020212022: 3022023: 30620232024: 2602025: 22020252026: 50

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.5%18
Malfunction99.5%3,310
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%3,327
Voluntary report0%1
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 19,425 reports carrying product code HWA. 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 broke2,96589.1%69.8%
Crackthe device cracked54116.3%8%
Naturally worn581.7%5.2%
Component missing331%0.3%
Scratched material170.5%1.2%
Fracturea broken bone160.5%6.1%
Contamination /decontamination problem120.4%1.4%
Material deformation90.3%3.8%
Material integrity problema problem with the device material90.3%0.8%
Material twisted/bent80.2%1.7%
Insufficient device problem information60.2%0.2%
Device-device incompatibility50.2%6%
Entrapment of device50.2%0.2%
Device or device fragments location unknown40.1%0%
Illegible information40.1%0.2%
Detachment of device or device componentpart of the device came off30.1%0.6%
Device contamination with chemical or other material20.1%0.1%
Corrodedthe device corroded10%0.1%
Expulsion10%0%
Material discolored10%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)ReportsShare
Not applicable170.5%
No patient involvement30.1%
Foreign body in patientpart of a device left in the patient10%

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

In context

MeasureAttune Femoral ImpactorProduct code HWAAll MAUDE reports
Reports3,32819,42526,136,888
Share of that pool—17.1%0%
Classified as death, per 1,000 reports009
Classified as injury0.5%1.8%36.2%
Classified as malfunction99.5%98%62.3%
Filed by the manufacturer100%99.5%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 HWA

BrandReportsLatest 12 monthsClassified as death
Pinn Straight Cup Impactor4,8073150%
Attune Fb Tibial Impactor1,9541140%
Attune Impaction Handle1,975640%
Attune Rp Tibial Impactor1,025320%
Sp2 Tibial Radel Impactor1,03920%
Duraloc Str Cup Impactor909570%
Concave Impactor Tip342180%
S/C Trial Handle Angled330320%
Duraloc Curved Cup Impactor310190%
Attune1,9581,9440%
Pinnacle6894990.1%
Sigma Hp Fbt Keel Punch Impact21900%
Sigma Hp Fem Notch Impactor26280%
Impactor F/Pfna Blade28400%
Sp 2 Femoral Impactor24620%

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 Attune Femoral Impactor reports

How many FDA reports name Attune Femoral Impactor?

3,328 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 121 in the latest 12 months.

What kinds of events are reported?

malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (89.1%), crack (16.3%), naturally worn (1.7%), component missing (1%) and scratched material (0.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Attune Femoral 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.