Device brand name · Attune instruments tibial trials
Attune Shim Sz5 5mm: medical device reports filed with FDA
181 reports name it, 2015–2026. Manufacturer given most often on reports: Depuy Ireland - 9616671. Product code HWT.
- 181
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 10
- reports, 12 months to August 2026
- 16 in the 12 months before
- 99.4%
- classified as malfunction
- 96.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 181 reports that name the brand "Attune Shim Sz5 5mm" (attune instruments tibial trials), received between June 2015 and March 2026; the manufacturer given most often on reports is Depuy Ireland - 9616671. Spellings of one product vary from report to report.
10 reports arrived in the 12 months to August 2026, down 37% from 16 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 (99.4%) and injury (0.6%); across all template reports (product code HWT) death is recorded in 0% and malfunction in 96.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (77.3%), crack (5.5%) and scratched material (4.4%). The patient problems coded most often are not applicable. 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 17,036 reports carrying product code HWT. 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 | 140 | 77.3% | 49.6% |
| Crackthe device cracked | 10 | 5.5% | 7.4% |
| Scratched material | 8 | 4.4% | 7.9% |
| Material integrity problema problem with the device material | 6 | 3.3% | 1.5% |
| Naturally worn | 4 | 2.2% | 9.9% |
| Material deformation | 3 | 1.7% | 5.3% |
| Material twisted/bent | 2 | 1.1% | 2.4% |
| Entrapment of device | 1 | 0.6% | 0.5% |
| Fracturea broken bone | 1 | 0.6% | 3.8% |
| Improper or incorrect procedure or method | 1 | 0.6% | 0.2% |
| Material discolored | 1 | 0.6% | 1% |
| Peeled/delaminated | 1 | 0.6% | 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 | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Attune Shim Sz5 5mm | Product code HWT | All MAUDE reports |
|---|---|---|---|
| Reports | 181 | 17,036 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.6% | 3.2% | 36.2% |
| Classified as malfunction | 99.4% | 96.7% | 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 HWT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Attune Spacer Block | 988 | 80 | 0% |
| Attune | 1,958 | 1,944 | 0% |
| Attune Mes Sizing/Rot Gde | 476 | 36 | 0% |
| Attune Distal Femoral Jig | 432 | 24 | 0% |
| Pfc Calibrated Pat Cut Gde | 425 | 1 | 0% |
| Articul Tr Ball Grvd 36 +1 5 | 344 | 11 | 0% |
| Attune Rp Ps Artic Surf Sz6 | 360 | 15 | 0% |
| Artic/Eze Tr Ball Grvd 32+1 | 285 | 1 | 0% |
| Offset Taper Adapter Trial | 170 | 40 | 0% |
| UNK Femoral Trial | 212 | 22 | 0% |
| Attune Fb Cr Artic Surf Sz6 | 270 | 31 | 0% |
| Articul Tr Ball Grvd 36 +5 | 234 | 6 | 0% |
| Attune Alignment Handle | 155 | 38 | 0% |
| Artic/Eze Tr Ball Grvd 32+5 | 207 | 0 | 0% |
| Attune Shim Sz7 5mm | 153 | 4 | 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 Attune Shim Sz5 5mm reports
How many FDA reports name Attune Shim Sz5 5mm?
181 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 10 in the latest 12 months.
What kinds of events are reported?
malfunction (99.4%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (77.3%), crack (5.5%), scratched material (4.4%), material integrity problem (3.3%) and naturally worn (2.2%). 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 Attune Shim Sz5 5mm 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.