Devices › Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Device brand name · Attune implant knee tibial insert
Attune: medical device reports filed with FDA
1,958 reports name it, 2015–2026. Manufacturer given most often on reports: Depuy Ireland - 9616671. Product code JWH.
- 1,958
- device reports naming the brand
- 0% of all MAUDE reports · about 175 a year
- 1,944
- reports, 12 months to August 2026
- 0 in the 12 months before
- 56.5%
- classified as malfunction
- 14.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,958 medical device reports received by FDA name the brand "Attune" (attune implant knee tibial insert); the manufacturer given most often on reports is Depuy Ireland - 9616671; received from May 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,944 reports arrived in the 12 months to August 2026, with 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 malfunction (56.5%) and injury (43.5%); across all prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer reports (product code JWH) death is recorded in 0.2% and malfunction in 14.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (32%), device-device incompatibility (7.2%) and crack (3.9%). The patient problems coded most often are joint laxity, pain and fall. 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 158,133 reports carrying product code JWH. 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 | 627 | 32% | 3.9% |
| Device-device incompatibility | 140 | 7.2% | 0.1% |
| Crackthe device cracked | 77 | 3.9% | 0.5% |
| Detachment of device or device componentpart of the device came off | 77 | 3.9% | 1.2% |
| Loss of or failure to bond | 62 | 3.2% | 6.3% |
| Peeled/delaminated | 60 | 3.1% | 0.1% |
| Material deformation | 40 | 2% | 0.2% |
| Contamination /decontamination problem | 37 | 1.9% | 0% |
| Osseointegration problem | 24 | 1.2% | 0.3% |
| Unintended movement | 24 | 1.2% | 0.3% |
| Difficult to insertthe device was hard to insert | 16 | 0.8% | 0.8% |
| Illegible information | 16 | 0.8% | 0% |
| Material discolored | 16 | 0.8% | 0.1% |
| Scratched material | 16 | 0.8% | 0.2% |
| Mechanical jam | 15 | 0.8% | 0.1% |
| Migrationthe device moved from where it was placed | 13 | 0.7% | 0.8% |
| Structural problem | 12 | 0.6% | 0% |
| Device dislodged or dislocated | 10 | 0.5% | 1.7% |
| Fracturea broken bone | 10 | 0.5% | 7.3% |
| Difficult to advance | 7 | 0.4% | 0% |
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 |
|---|---|---|
| Joint laxity | 173 | 8.8% |
| Painpain, site not specified | 140 | 7.2% |
| Falla fall | 36 | 1.8% |
| Loss of range of motion | 31 | 1.6% |
| Adhesion(s) | 26 | 1.3% |
| Muscular rigidity | 26 | 1.3% |
| Inadequate osseointegration | 24 | 1.2% |
| Limb fracture | 13 | 0.7% |
| Hypersensitivity/allergic reaction | 12 | 0.6% |
| Wound dehiscencea wound reopened | 11 | 0.6% |
| Bone notching | 9 | 0.5% |
| Osteolysis | 9 | 0.5% |
| Bone fracture(s) | 8 | 0.4% |
| Ambulation or postural difficulties | 7 | 0.4% |
| Hemorrhage/blood loss/bleeding | 7 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Attune | Product code JWH | All MAUDE reports |
|---|---|---|---|
| Reports | 1,958 | 158,133 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 43.5% | 84.1% | 36.2% |
| Classified as malfunction | 56.5% | 14.7% | 62.3% |
| Filed by the manufacturer | 99.6% | 98.4% | 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 JWH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Knee Tibial Insert | 2,247 | 130 | 0.2% |
| Unknown Knee Femoral | 1,897 | 65 | 0.2% |
| Unknown Knee Tibial Tray | 1,958 | 57 | 0.2% |
| Persona Tibial Articular Surface Provisional | 1,584 | 0 | 0% |
| Itotal G2 | 1,250 | 0 | 0% |
| Specific Device Not Reported | 1,462 | 20 | 0.2% |
| Apex Knee System | 1,001 | 49 | 0% |
| Djo Surgical | 4,713 | 2,448 | 0% |
| Unknown Knee | 1,847 | 18 | 1.5% |
| Attune Fb Tib Base Sz 5 Cem | 863 | 18 | 0% |
| Attune Fb Tib Base Sz 4 Cem | 797 | 14 | 0% |
| Pfc Sigma/Ov/Dome Pat 3peg 38 | 806 | 3 | 0.4% |
| Unknown Knee Patella | 791 | 26 | 0.4% |
| Unknown Reconstructive Product | 2,579 | 0 | 0.4% |
| UNK Attune Knee Tibial Insert | 895 | 102 | 0.1% |
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 reports
How many FDA reports name Attune?
1,958 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,944 in the latest 12 months.
What kinds of events are reported?
malfunction (56.5%) and injury (43.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (32%), device-device incompatibility (7.2%), crack (3.9%), detachment of device or device component (3.9%) and loss of or failure to bond (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Attune 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.