R1 Reverse Shoulder System 1230-7504-003Recalls & reported problems
Catalyst Orthoscience Inc. · Poly Insert 36mm +8 · Class 2 · Implant
All models of R1 Reverse Shoulder System (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811596030469), received between Mar 10, 2022 and Feb 17, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ORIGINAL SURGERY WAS COMPLETED ON (B)(6) 2021. THE PATIENT IGNORED GUIDELINES PROVIDED BY SURGEON AND WAS PLAYING FULL-CONTACT ICE HOCKEY, WHERE HE WAS CHECKED AND LANDED ON HIS SHOULDER. REVISION SURGERY WAS COMPLETED ON (B)(6) 2023 WHERE POLY INSERT IMPLANT SIZE 36 +8 WAS REMOVED AND UPSIZED TO A SEMI-CONSTRAINED POLY INSERT IMPLANT SIZE 36 +0 AND HUMERAL SPACER IMPLANT +12.
Patient problems: Failure of Implant
MAUDE report 16400577 ↗InjuryMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD USED THEIR ARM TO PUSH THEMSELVES UP AND OUT OF BED IN AN AWKWARD MANNER APPROXIMATELY 02 MONTHS FOLLOWING PREVIOUS SHOULDER ARTHROPLASTY. THE SURGEON REPORTED THAT THE HUMERAL INSERT WAS DISASSOCIATED FROM THE HUMERAL STEM. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE HUMERAL INSERT WITH AN EQUIVALENT SIZE HUMERAL INSERT. THE IMPLANT HAS BEEN RETURNED FOR INVESTIGATION.
Patient problems: Failure of Implant
MAUDE report 13722515 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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