Devices › Shoulder prosthesis, reverse configuration
Device brand name · Rsp baseplate 30mm w/p2 coating
Rsp: medical device reports filed with FDA
1,369 reports name it, 2007–2023. Manufacturer given most often on reports: Encore Medical L P. Product code PHX.
- 1,369
- device reports naming the brand
- 0% of all MAUDE reports · about 71 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.7%
- classified as malfunction
- 11.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,369 medical device reports received by FDA name the brand "Rsp" (rsp baseplate 30mm w/p2 coating); the manufacturer given most often on reports is Encore Medical L P; received from March 2007 to November 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 injury (96%), other (2.3%) and malfunction (1.7%); 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 (25%), break (7.5%) and unstable (6.1%). The patient problems coded most often are joint dislocation, pain and failure of implant. 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 | 342 | 25% | 19% |
| Breakthe device broke | 102 | 7.5% | 3.3% |
| Unstable | 84 | 6.1% | 5.5% |
| Loose or intermittent connection | 60 | 4.4% | 1.4% |
| Fracturea broken bone | 33 | 2.4% | 7.2% |
| Loosening of implant not related to bone-ingrowth | 28 | 2% | 3.9% |
| Insufficient device problem information | 18 | 1.3% | 1.1% |
| Detachment of device or device componentpart of the device came off | 9 | 0.7% | 3.2% |
| Naturally worn | 6 | 0.4% | 1.3% |
| Inadequacy of device shape and/or size | 5 | 0.4% | 0.4% |
| Malposition of device | 5 | 0.4% | 0.5% |
| Therapeutic or diagnostic output failure | 5 | 0.4% | 0.1% |
| Device slipped | 4 | 0.3% | 0.2% |
| Labelling, instructions for use or training problem | 4 | 0.3% | 0% |
| Material separation | 3 | 0.2% | 0.2% |
| Migration or expulsion of device | 3 | 0.2% | 0.1% |
| Crackthe device cracked | 2 | 0.1% | 0.1% |
| Difficult to removethe device was hard to remove | 2 | 0.1% | 0.1% |
| Improper or incorrect procedure or method | 2 | 0.1% | 0.3% |
| Material deformation | 2 | 0.1% | 0.4% |
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 | 240 | 17.5% |
| Painpain, site not specified | 113 | 8.3% |
| Failure of implant | 110 | 8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 64 | 4.7% |
| Joint laxity | 61 | 4.5% |
| Falla fall | 42 | 3.1% |
| Medical device site infectioninfection at the device site | 36 | 2.6% |
| Bone fracture(s) | 24 | 1.8% |
| Loss of range of motion | 14 | 1% |
| Bacterial infectiona bacterial infection | 9 | 0.7% |
| Discomfortdiscomfort | 6 | 0.4% |
| Fluid discharge | 4 | 0.3% |
| Device embedded in tissue or plaque | 2 | 0.1% |
| Erythemaskin redness | 2 | 0.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Rsp | Product code PHX | All MAUDE reports |
|---|---|---|---|
| Reports | 1,369 | 13,005 | 26,136,888 |
| Share of that pool | — | 10.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 96% | 88.7% | 36.2% |
| Classified as malfunction | 1.7% | 11.2% | 62.3% |
| Filed by the manufacturer | 100% | 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 |
|---|---|---|---|
| Djo Surgical | 4,713 | 2,448 | 0% |
| Humelock Reversed | 666 | 48 | 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 Rsp reports
How many FDA reports name Rsp?
1,369 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?
injury (96%), other (2.3%) and malfunction (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (25%), break (7.5%), unstable (6.1%), loose or intermittent connection (4.4%) and fracture (2.4%). 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 Rsp 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.