Devices › Shoulder prosthesis, reverse configuration
Device brand name · Reversed shoulder prosthesis
Humelock Reversed: medical device reports filed with FDA
666 reports name it, 2019–2026. Manufacturer given most often on reports: Fx Solutions. Product code PHX.
- 666
- device reports naming the brand
- 0% of all MAUDE reports · about 92 a year
- 48
- reports, 12 months to August 2026
- 77 in the 12 months before
- 0.5%
- classified as malfunction
- 11.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
666 medical device reports received by FDA name the brand "Humelock Reversed" (reversed shoulder prosthesis); the manufacturer given most often on reports is Fx Solutions; received from April 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
48 reports arrived in the 12 months to August 2026, down 38% from 77 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 (99.5%) and malfunction (0.5%); across all shoulder prosthesis, reverse configuration reports (product code PHX) death is recorded in 0.1% and malfunction in 11.2%. 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 (24.2%), unstable (5.6%) and microbial contamination of device (2.1%). The patient problems coded most often are joint dislocation, medical device site infection 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 13,005 reports carrying product code PHX. 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 | 161 | 24.2% | 19% |
| Unstable | 37 | 5.6% | 5.5% |
| Microbial contamination of device | 14 | 2.1% | 0.3% |
| Fracturea broken bone | 11 | 1.7% | 7.2% |
| Improper or incorrect procedure or method | 10 | 1.5% | 0.3% |
| Migrationthe device moved from where it was placed | 10 | 1.5% | 0.9% |
| Loose or intermittent connection | 9 | 1.4% | 1.4% |
| Loosening of implant not related to bone-ingrowth | 8 | 1.2% | 3.9% |
| Material separation | 7 | 1.1% | 0.2% |
| Breakthe device broke | 6 | 0.9% | 3.3% |
| Detachment of device or device componentpart of the device came off | 4 | 0.6% | 3.2% |
| Output problem | 3 | 0.5% | 0.1% |
| Insufficient device problem information | 2 | 0.3% | 1.1% |
| Naturally worn | 2 | 0.3% | 1.3% |
| Entrapment of device | 1 | 0.2% | 0% |
| Excessive cooling | 1 | 0.2% | 0% |
| Inaccurate information | 1 | 0.2% | 0% |
| Inadequate user interface | 1 | 0.2% | 0% |
| Malposition of device | 1 | 0.2% | 0.5% |
| Migration or expulsion of device | 1 | 0.2% | 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 |
|---|---|---|
| Joint dislocationa dislocated joint | 133 | 20% |
| Medical device site infectioninfection at the device site | 91 | 13.7% |
| Joint laxity | 53 | 8% |
| Falla fall | 48 | 7.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 34 | 5.1% |
| Failure of implant | 29 | 4.4% |
| Subluxation | 13 | 2% |
| Implant pain | 10 | 1.5% |
| Inadequate osseointegration | 6 | 0.9% |
| Painpain, site not specified | 5 | 0.8% |
| Bone fracture(s) | 4 | 0.6% |
| Bacterial infectiona bacterial infection | 2 | 0.3% |
| Damage to ligament(s) | 2 | 0.3% |
| Loss of range of motion | 2 | 0.3% |
| Sepsisa severe body-wide response to infection | 2 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Humelock Reversed | Product code PHX | All MAUDE reports |
|---|---|---|---|
| Reports | 666 | 13,005 | 26,136,888 |
| Share of that pool | — | 5.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 99.5% | 88.7% | 36.2% |
| Classified as malfunction | 0.5% | 11.2% | 62.3% |
| Filed by the manufacturer | 86% | 98.5% | 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 PHX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Rsp | 1,369 | 0 | 0% |
| Djo Surgical | 4,713 | 2,448 | 0% |
| Rsp Shoulder | 2,006 | 0 | 0% |
| Shoulder System | 321 | 153 | 0% |
| Humeris | 239 | 2 | 0% |
| Equinoxe Reverse Shoulder Components | 440 | 200 | 0% |
| Compr Metal Impactor | 342 | 37 | 0% |
| Unknown Shoulder Locking Screw | 539 | 25 | 0.4% |
| SMR Shoulder | 257 | 161 | 0% |
| Unknown Glenoid | 216 | 26 | 0% |
| Inhance | 589 | 589 | 0% |
| Comp Rvrs 25mm Bsplt Ha+adptr | 239 | 17 | 0% |
| Unknown Shoulder Humeral Cup | 252 | 12 | 0.4% |
| Unknown Peripheral Screw | 156 | 24 | 0% |
| Altivate Reverse Shoulder | 500 | 0 | 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 Humelock Reversed reports
How many FDA reports name Humelock Reversed?
666 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 48 in the latest 12 months.
What kinds of events are reported?
injury (99.5%) and malfunction (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (24.2%), unstable (5.6%), microbial contamination of device (2.1%), fracture (1.7%) and improper or incorrect procedure or method (1.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (86%) and distributor reports (14%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Humelock Reversed 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.