Devices › Prosthesis, shoulder, semi-constrained, metal/polymer cemented
Device brand name · Primary humeral stem male taper
Foundation Shoulder: medical device reports filed with FDA
152 reports name it, 2010–2021. Manufacturer given most often on reports: Encore Medical L P. Product code KWS.
- 152
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.3%
- classified as malfunction
- 10.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 152 reports that name the brand "Foundation Shoulder" (primary humeral stem male taper), received between June 2010 and November 2021; the manufacturer given most often on reports is Encore Medical L P. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and 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 other (64.5%), injury (31.6%) and malfunction (1.3%); across all prosthesis, shoulder, semi-constrained, metal/polymer cemented reports (product code KWS) death is recorded in 0.1% and malfunction in 10.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (23%), device operates differently than expected (17.1%) and loose or intermittent connection (5.3%). The patient problems coded most often are pain, laceration(s) 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 23,454 reports carrying product code KWS. 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 |
|---|---|---|---|
| Insufficient device problem information | 35 | 23% | 10.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 26 | 17.1% | 1.5% |
| Loose or intermittent connection | 8 | 5.3% | 2.5% |
| Device dislodged or dislocated | 7 | 4.6% | 15.5% |
| Device slipped | 6 | 3.9% | 1.7% |
| Human-device interface problem | 6 | 3.9% | 0.2% |
| Naturally worn | 6 | 3.9% | 2.7% |
| Unstable | 5 | 3.3% | 5.1% |
| Inadequacy of device shape and/or size | 4 | 2.6% | 0.7% |
| Torn material | 4 | 2.6% | 0.3% |
| Breakthe device broke | 2 | 1.3% | 3.9% |
| Device inoperablethe device could not be used | 2 | 1.3% | 0.1% |
| Fracturea broken bone | 2 | 1.3% | 7.8% |
| Defective devicethe device was defective | 1 | 0.7% | 0.1% |
| Improper or incorrect procedure or method | 1 | 0.7% | 0.3% |
| Malposition of device | 1 | 0.7% | 0.9% |
| Material erosion | 1 | 0.7% | 0.2% |
| Material rupture | 1 | 0.7% | 0% |
| Structural problem | 1 | 0.7% | 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 |
|---|---|---|
| Painpain, site not specified | 18 | 11.8% |
| Laceration(s) | 10 | 6.6% |
| Falla fall | 9 | 5.9% |
| Limited mobility of the implanted joint | 5 | 3.3% |
| Tissue damage | 5 | 3.3% |
| Joint disorder | 4 | 2.6% |
| Failure of implant | 2 | 1.3% |
| Injurya physical injury | 2 | 1.3% |
| Nonunion/delayed-union bone fracture | 2 | 1.3% |
| Ambulation or postural difficulties | 1 | 0.7% |
| Arthralgiajoint pain | 1 | 0.7% |
| Arthritis | 1 | 0.7% |
| Damage to ligament(s) | 1 | 0.7% |
| Discomfortdiscomfort | 1 | 0.7% |
| Excessive tear production | 1 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Foundation Shoulder | Product code KWS | All MAUDE reports |
|---|---|---|---|
| Reports | 152 | 23,454 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 31.6% | 83.5% | 36.2% |
| Classified as malfunction | 1.3% | 10.9% | 62.3% |
| Filed by the manufacturer | 100% | 99.4% | 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 KWS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Rsp Shoulder | 2,006 | 0 | 0% |
| Djo Surgical | 4,713 | 2,448 | 0% |
| Turon Shoulder | 547 | 0 | 0% |
| Altivate Reverse Shoulder | 500 | 0 | 0% |
| Unknown Shoulder Glenosphere | 335 | 24 | 0.3% |
| Modular Center Post Reamer | 173 | 21 | 0% |
| Compr Metal Impactor | 342 | 37 | 0% |
| Comp Rvrs 25mm Bsplt Ha+adptr | 239 | 17 | 0% |
| Altivate Anatomic Shoulder | 150 | 0 | 0% |
| Unknown Shoulder Humeral Stems | 239 | 8 | 1.7% |
| Unknown Shoulder Implant | 254 | 8 | 0.8% |
| Dxtend Glenosphere Std D38mm | 323 | 5 | 0% |
| Unknown Shoulder Metaglene | 305 | 16 | 0.3% |
| Dxtend Metaglene | 355 | 14 | 0% |
| Unknown Shoulder Humeral Cup | 252 | 12 | 0.4% |
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 Foundation Shoulder reports
How many FDA reports name Foundation Shoulder?
152 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
other (64.5%), injury (31.6%) and malfunction (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (23%), device operates differently than expected (17.1%), loose or intermittent connection (5.3%), device dislodged or dislocated (4.6%) and device slipped (3.9%). 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 Foundation Shoulder 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.