R1 Reverse Shoulder System 1230-7505-003Recalls & reported problems
Catalyst Orthoscience Inc. · Poly Insert 40mm +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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811596030506), received between Mar 10, 2022 and Oct 5, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Dislocated4
Patient problems
- Failure of Implant4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY AND APPROXIMATELY 08 MONTHS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL STEM. THE PATIENT DID NOT REPORT ANY SPECIFIC EVENT THAT MAY HAVE CAUSED THE DISSOCIATION OF THE INSERT. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. CUSTOMER HAS INDICATED THAT THE IMPLANTS WILL NOT BE RETURNED FOR INVESTIGATION AS THE IMPLANTS WERE DISCARDED BY THE HOSPITAL.
Patient problems: Failure of Implant
MAUDE report 15546559 ↗InjuryApr 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY AND APPROXIMATELY 03 WEEKS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL STEM. THE PATIENT DID NOT REPORT ANY SPECIFIC EVENT THAT MAY HAVE CAUSED THE DISSOCIATION OF THE INSERT. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. CUSTOMER HAS INDICATED THAT THE IMPLANTS WILL NOT BE RETURNED FOR INVESTIGATION AS THE IMPLANTS WERE DISCARDED BY THE HOSPITAL.
Patient problems: Failure of Implant
MAUDE report 14240486 ↗InjuryApr 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS BEING STRETCHED DURING PHYSICAL THERAPY WITH HIS ARM IN EXTREME ABDUCTION WHEN HE FELT A POP IN HIS SHOULDER. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE AND REPLACE THE HUMERAL INSERT AND HUMERAL STEM WITH ANOTHER MANUFACTURER'S DEVICE AN UNKNOWN NUMBER OF MONTHS (AT MOST 07 MONTHS) AFTER THE PREVIOUS SURGERY. THE HUMERAL INSERT WAS FOUND TO BE DISSOCIATED FROM THE HUMERAL STEM. CUSTOMER HAS INDICATED THAT THE IMPLANTS WILL NOT BE RETURNED FOR INVESTIGATION AS THE IMPLANTS WERE DISCARDED BY THE HOSPITAL.
Patient problems: Failure of Implant
MAUDE report 14074934 ↗InjuryMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
HOLD FOR KP 3.10IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY AND APPROXIMATELY 02 MONTHS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL STEM. THE PREVIOUS HUMERAL INSERT AND HUMERAL STEM WERE REPLACED WITH A NEW INSERT AND STEM. THE PATIENT DID NOT REPORT ANY SPECIFIC EVENT THAT MAY HAVE CAUSED THE DISSOCIATION OF THE INSERT. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. CUSTOMER HAS INDICATED THAT THE IMPLANTS WILL NOT BE RETURNED FOR INVESTIGATION AS THE IMPLANTS WERE DISCARDED BY THE HOSPITAL.
Patient problems: Failure of Implant
MAUDE report 13722506 ↗
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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