Devices › Prosthesis, shoulder, semi-constrained, metal/polymer cemented
Device brand name · Prosthesis shoulder
Unknown Humeral Stem: medical device reports filed with FDA
162 reports name it, 2017–2026. Manufacturer given most often on reports: Zimmer Biomet. Product code KWS.
- 162
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 15
- reports, 12 months to August 2026
- 18 in the 12 months before
- 0.6%
- classified as malfunction
- 10.9% across the product code
- 1.2%
- classified as death, as reported
- 2 reports · not verified by FDA
162 medical device reports received by FDA name the brand "Unknown Humeral Stem" (prosthesis shoulder); the manufacturer given most often on reports is Zimmer Biomet; received from July 2017 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
15 reports arrived in the 12 months to August 2026, down 17% from 18 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 (98.1%), death (1.2%) and malfunction (0.6%); 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 (23.5%), loosening of implant not related to bone-ingrowth (5.6%) and loss of osseointegration (2.5%). The patient problems coded most often are pain, loss of range of motion and osteolysis. 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 | 38 | 23.5% | 10.3% |
| Loosening of implant not related to bone-ingrowth | 9 | 5.6% | 3.7% |
| Loss of osseointegration | 4 | 2.5% | 1.9% |
| Migration or expulsion of device | 4 | 2.5% | 1.1% |
| Detachment of device or device componentpart of the device came off | 3 | 1.9% | 2% |
| Naturally worn | 3 | 1.9% | 2.7% |
| Material erosion | 2 | 1.2% | 0.2% |
| Migrationthe device moved from where it was placed | 2 | 1.2% | 1.2% |
| Device dislodged or dislocated | 1 | 0.6% | 15.5% |
| Fracturea broken bone | 1 | 0.6% | 7.8% |
| Lack of effect | 1 | 0.6% | 0.1% |
| Malposition of device | 1 | 0.6% | 0.9% |
| Mechanical problema mechanical problem | 1 | 0.6% | 0.5% |
| Unintended system motionthe device moved when it should not have | 1 | 0.6% | 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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 27 | 16.7% |
| Loss of range of motion | 9 | 5.6% |
| Osteolysis | 6 | 3.7% |
| Failure of implant | 5 | 3.1% |
| Bone fracture(s) | 4 | 2.5% |
| Aseptic loosening | 3 | 1.9% |
| Implant site sclerosis | 3 | 1.9% |
| Joint laxity | 3 | 1.9% |
| Muscle weakness/atrophy | 3 | 1.9% |
| Deaththe patient died; cause not stated by this term | 2 | 1.2% |
| Hypersensitivity/allergic reaction | 2 | 1.2% |
| Inflammationinflammation | 2 | 1.2% |
| Metal related pathology | 2 | 1.2% |
| Neuropathy | 2 | 1.2% |
| Post operative wound infection | 2 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Humeral Stem | Product code KWS | All MAUDE reports |
|---|---|---|---|
| Reports | 162 | 23,454 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 12 | 1 | 9 |
| Classified as injury | 98.1% | 83.5% | 36.2% |
| Classified as malfunction | 0.6% | 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% |
| Foundation Shoulder | 152 | 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% |
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 Unknown Humeral Stem reports
How many FDA reports name Unknown Humeral Stem?
162 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.
What kinds of events are reported?
injury (98.1%), death (1.2%) and malfunction (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (23.5%), loosening of implant not related to bone-ingrowth (5.6%), loss of osseointegration (2.5%), migration or expulsion of device (2.5%) and detachment of device or device component (1.9%). 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 Unknown Humeral Stem 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.