Devices › Prosthesis, shoulder, non-constrained, metal/polymer cemented
Device brand name · Prosthesis shoulder non-constrained metal/polymer cemented
Equinoxe Reverse Shoulder Components: medical device reports filed with FDA
440 reports name it, 2022–2026. Manufacturer given most often on reports: Exactech. Product code KWT.
- 440
- device reports naming the brand
- 0% of all MAUDE reports · about 115 a year
- 200
- reports, 12 months to August 2026
- 164 in the 12 months before
- 0.2%
- classified as malfunction
- 12.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
440 medical device reports received by FDA name the brand "Equinoxe Reverse Shoulder Components" (prosthesis shoulder non-constrained metal/polymer cemented); the manufacturer given most often on reports is Exactech; received from September 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
200 reports arrived in the 12 months to August 2026, up 22% from 164 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 (99.8%) and malfunction (0.2%); across all prosthesis, shoulder, non-constrained, metal/polymer cemented reports (product code KWT) death is recorded in 0.2% and malfunction in 12.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (28.9%), unstable (13.9%) and insufficient device problem information (4.3%). The patient problems coded most often are joint dislocation, pain and joint laxity. 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 5,693 reports carrying product code KWT. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 127 | 28.9% | 16.4% |
| Unstable | 61 | 13.9% | 5.1% |
| Insufficient device problem information | 19 | 4.3% | 10.6% |
| Lack of effect | 12 | 2.7% | 0.5% |
| Loosening of implant not related to bone-ingrowth | 5 | 1.1% | 6% |
| Naturally worn | 5 | 1.1% | 7.2% |
| Fracturea broken bone | 3 | 0.7% | 7.8% |
| Mechanical problema mechanical problem | 3 | 0.7% | 0.8% |
| Detachment of device or device componentpart of the device came off | 2 | 0.5% | 8.5% |
| Noise, audible | 2 | 0.5% | 0.4% |
| Audible prompt/feedback problem | 1 | 0.2% | 0% |
| Device appears to trigger rejection | 1 | 0.2% | 0% |
| Failure to osseointegrate | 1 | 0.2% | 0% |
| Unintended movement | 1 | 0.2% | 0.3% |
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 dislocationa dislocated joint | 121 | 27.5% |
| Painpain, site not specified | 89 | 20.2% |
| Joint laxity | 59 | 13.4% |
| Bone fracture(s) | 50 | 11.4% |
| Failure of implant | 20 | 4.5% |
| Loss of range of motion | 18 | 4.1% |
| Subluxation | 17 | 3.9% |
| Medical device site infectioninfection at the device site | 14 | 3.2% |
| Joint impingement | 10 | 2.3% |
| Bacterial infectiona bacterial infection | 9 | 2% |
| Nerve damage | 9 | 2% |
| Osteolysis | 7 | 1.6% |
| Periprosthetic fracture | 7 | 1.6% |
| Discomfortdiscomfort | 6 | 1.4% |
| Muscle/tendon damage | 6 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Equinoxe Reverse Shoulder Components | Product code KWT | All MAUDE reports |
|---|---|---|---|
| Reports | 440 | 5,693 | 26,136,888 |
| Share of that pool | — | 7.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 99.8% | 85.7% | 36.2% |
| Classified as malfunction | 0.2% | 12.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.2% | 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 KWT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Equinoxe | 1,251 | 108 | 0.1% |
| Specific Device Not Reported | 1,462 | 20 | 0.2% |
| Equinoxe Reverse Humeral Adapter Tray | 161 | 0 | 0% |
| Equinoxe Reverse Humeral Liner | 173 | 0 | 0% |
| SMR Shoulder | 257 | 161 | 0% |
| Modular Center Post Reamer | 173 | 21 | 0% |
| Screw | 647 | 0 | 0% |
| Unknown Extremity | 155 | 0 | 1.9% |
| Comp Rvrs 25mm Bsplt Ha+adptr | 239 | 17 | 0% |
| Exactech | 576 | 0 | 0% |
| Unk head | 405 | 146 | 0.5% |
| Unk Reamer | 833 | 71 | 0% |
| Unknown Knee Components | 312 | 42 | 0.3% |
| Unknown Shoulder Humeral Stems | 239 | 8 | 1.7% |
| Unknown Shoulder Implant | 254 | 8 | 0.8% |
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 Equinoxe Reverse Shoulder Components reports
How many FDA reports name Equinoxe Reverse Shoulder Components?
440 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 200 in the latest 12 months.
What kinds of events are reported?
injury (99.8%) and malfunction (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (28.9%), unstable (13.9%), insufficient device problem information (4.3%), lack of effect (2.7%) and loosening of implant not related to bone-ingrowth (1.1%). 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 Equinoxe Reverse Shoulder Components 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.