Devices › Prosthesis, shoulder, semi-constrained, metal/polymer cemented
Device brand name · Shoulder humeral heads
Unknown Shoulder Glenosphere: medical device reports filed with FDA
335 reports name it, 2018–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code KWS.
- 335
- device reports naming the brand
- 0% of all MAUDE reports · about 39 a year
- 24
- reports, 12 months to August 2026
- 39 in the 12 months before
- 1.5%
- classified as malfunction
- 10.9% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 335 reports that name the brand "Unknown Shoulder Glenosphere" (shoulder humeral heads), received between January 2018 and July 2026; the manufacturer given most often on reports is Depuy Orthopaedics US. Spellings of one product vary from report to report.
24 reports arrived in the 12 months to August 2026, down 38% from 39 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 (98.2%), malfunction (1.5%) and death (0.3%); 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 device dislodged or dislocated (58.5%), insufficient device problem information (6.6%) and fracture (2.4%). The patient problems coded most often are joint dislocation, pain and 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 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 |
|---|---|---|---|
| Device dislodged or dislocated | 196 | 58.5% | 15.5% |
| Insufficient device problem information | 22 | 6.6% | 10.3% |
| Fracturea broken bone | 8 | 2.4% | 7.8% |
| Disconnection | 3 | 0.9% | 0.1% |
| Naturally worn | 3 | 0.9% | 2.7% |
| Detachment of device or device componentpart of the device came off | 2 | 0.6% | 2% |
| Difficult to insertthe device was hard to insert | 2 | 0.6% | 0.9% |
| Disassembly | 2 | 0.6% | 0.6% |
| Noise, audible | 2 | 0.6% | 0.4% |
| Device-device incompatibility | 1 | 0.3% | 0.1% |
| Difficult to removethe device was hard to remove | 1 | 0.3% | 0.2% |
| Improper or incorrect procedure or method | 1 | 0.3% | 0.3% |
| Loss of or failure to bond | 1 | 0.3% | 1.1% |
| Loss of osseointegration | 1 | 0.3% | 1.9% |
| Malposition of device | 1 | 0.3% | 0.9% |
| Migrationthe device moved from where it was placed | 1 | 0.3% | 1.2% |
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 | 188 | 56.1% |
| Painpain, site not specified | 47 | 14% |
| Not applicable | 42 | 12.5% |
| Joint laxity | 26 | 7.8% |
| Hematomaa collection of blood under the skin or in tissue | 15 | 4.5% |
| Bone fracture(s) | 11 | 3.3% |
| Injurya physical injury | 9 | 2.7% |
| Loss of range of motion | 8 | 2.4% |
| Discomfortdiscomfort | 4 | 1.2% |
| Falla fall | 3 | 0.9% |
| Hypersensitivity/allergic reaction | 3 | 0.9% |
| Swellingswelling | 3 | 0.9% |
| Extraskeletal ossification | 2 | 0.6% |
| Foreign body reaction | 2 | 0.6% |
| Joint disorder | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Shoulder Glenosphere | Product code KWS | All MAUDE reports |
|---|---|---|---|
| Reports | 335 | 23,454 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 3 | 1 | 9 |
| Classified as injury | 98.2% | 83.5% | 36.2% |
| Classified as malfunction | 1.5% | 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% |
| 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% |
| 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 Unknown Shoulder Glenosphere reports
How many FDA reports name Unknown Shoulder Glenosphere?
335 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 24 in the latest 12 months.
What kinds of events are reported?
injury (98.2%), malfunction (1.5%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (58.5%), insufficient device problem information (6.6%), fracture (2.4%), disconnection (0.9%) and naturally worn (0.9%). 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 Shoulder Glenosphere 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.