R1 Reverse Shoulder SystemRecalls & reported problems across all models

We found 8 models of R1 Reverse Shoulder System by Catalyst Orthoscience Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2022 and May 20, 2024 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported R1 Reverse Shoulder System problems

R1 Reverse Shoulder System models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• R1 Reverse Shoulder System 1230-7504-002

  Shoulder Prosthesis, Reverse Configuration
  5 reports
• R1 Reverse Shoulder System 1230-7505-003

  Shoulder Prosthesis, Reverse Configuration
  4 reports
• R1 Reverse Shoulder System 1230-7504-004

  Shoulder Prosthesis, Reverse Configuration
  3 reports
• R1 Reverse Shoulder System 1230-7505-002

  Shoulder Prosthesis, Reverse Configuration
  3 reports
• R1 Reverse Shoulder System 1230-7504-003

  Shoulder Prosthesis, Reverse Configuration
  2 reports
• R1 Reverse Shoulder System 1230-7505-004

  Shoulder Prosthesis, Reverse Configuration
  1 report
• R1 Reverse Shoulder System 1230-7512-002

  Shoulder Prosthesis, Reverse Configuration
  1 report
• R1 Reverse Shoulder System 1230-7513-002

  Shoulder Prosthesis, Reverse Configuration
  1 report

Recent R1 Reverse Shoulder System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023. DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 1 YEAR 3 MONTHS. PATIENT REPORTED A FALL WHILE WALKING DOG TO SURGEON WHEN BEING EVALUATED FOR POSSIBLE DISLOCATION. FOLLOWING REVISION, IT WAS REPORTED THAT THE POLY INSERT HAD DISSOCIATED FROM THE HUMERAL STEM. REVISION SURGEON REMOVED POLY INSERT 36MM +4 P/N 1230-7504-002 AND IMPLANTED NEW POLY INSERT 36MM + 0 P/N 1230-7518-001, HUMERAL SPACER +8MM P/N 1230-7522-001, AND SPACER LOCKING SCREW P/N 1230-7521-001.

  Patient problems: Failure of Implant

  MAUDE report 19354755 ↗
• InjuryMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL SURGERY WAS PERFORMED ON (B)(6) 2022. DEVICE HAD BEEN IMPLANTED FOR APPROXIMATELY 1 YEAR 7 MONTHS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, SPECIFIC REASON AND/OR PATIENT EVENT NECESSITATING REVISION WAS NOT REPORTED. FOLLOWING REVISION, IT WAS REPORTED THAT THE POLY INSERT HAD DISSOCIATED FROM THE HUMERAL STEM. REVISION SURGEON REMOVED POLY INSERT 36MM +4 P/N (B)(4) AND IMPLANTED NEW POLY INSERT 36MM +0 P/N P/N (B)(4), HUMERAL SPACER +8MM P/N (B)(4) AND SPACER LOCKING SCREW P/N (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 19278751 ↗
• InjuryApr 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL SURGERY WAS PERFORMED ON (B)(6) 2023 AND DEVICE HAD BEEN IMPLANTED FOR ALMOST 10 MONTHS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, SPECIFIC REASON AND/OR PATIENT EVENT NECESSITATING REVISION WAS NOT REPORTED. FOLLOWING REVISION, IT WAS REPORTED THAT THE POLY INSERT HAD DISSOCIATED FROM THE HUMERAL STEM. REVISION SURGEON REPORTED THE HUMERAL STEM WAS FIRMLY FIXED AND A NEW SEMI-CONSTRAINED POLY INSERT, HUMERAL SPACER +12 AND A GLENOSPHERES XLT WERE IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19089554 ↗
• InjuryJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE POLY INSERT WAS IMPLANTED ON (B)(6) 2022. THE PATIENT REPORTED A TRAUMATIC FALL AND A REVISION SURGERY ON (B)(6) 2023 WAS PERFORMED AND NOTED THE POLY HAD DISSOCIATED FROM THE HUMERAL STEM.

  Patient problems: Failure of Implant

  MAUDE report 17069986 ↗
• InjuryApr 6, 2023Unstable; Unstable

  ORIGINAL SURGERY WAS (B)(6) 2022. FIRST REVISION WAS (B)(6) 2023 FOR AN INSTABILITY EVENT. PATIENT HAD A SECOND INSTABILITY EVENT AND SURGEON REVISED AGAIN, UTILIZING ONLAY DESIGN. THERE WAS NO REPORT OF A TRAUMATIC EVENT AND THIS WAS THE FIRST NOTIFICATION OF BOTH REVISION SURGERIES. WHEN REMOVING THE IMPLANT, THE GLENOSPHERE, GLENOSPHERE LOCKING SCREW AND BASEPLATE LOCKING CAP CAME OFF IN ONE PIECE.

  Patient problems: Failure of Implant

  MAUDE report 16689179 ↗
• InjuryMar 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL SURGERY WAS PERFORMED ON (B)(6) 2022 USING CATALYST IMPLANTS FOR THE GLENOID SIDE AND A LIMA STEM ON THE HUMERAL SIDE. IN (B)(6) 2023, THE PATIENT REPORTED STABILITY ISSUES. UPON FURTHER EXAMINATION, THE GLENOSPHERE HAD DISSOCIATED FROM THE BASEPLATE. THE PATIENT DID NOT REPORT A TRAUMATIC EVENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, THE GLENOSPHERE IMPLANT SIZE 36 LAT AND BASEPLATE WERE REMOVED AND REPLACED WITH THE SAME TYPE/SIZE OF CONSTRUCT WITH NO FURTHER ISSUES IDENTIFIED.

  Patient problems: Failure of Implant

  MAUDE report 16567294 ↗
• 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 ↗
• InjuryFeb 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULD ARTHROPLASTY SURGERY AND APPROXIMATELY 13 MONTHS LATER WAS REVISED DUE TO INSTABILITY AND DISLOCATION. DURING SURGERY IT WAS DISCOVERED THAT THE POLY INSERT WAS IN THE STEM, BUT COULD BE REMOVED BY HAND. THE POLY INSERT WAS EXPLANTED. THE PATIENT DID NOT REPORT ANY SPECIFIC EVENT THAT MAY HAVE CAUSED THE DISLOCATION. CUSTOMER HAS INDICATED THAT THE IMPLANT WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 16294407 ↗
• InjuryOct 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SHOULDER ARTHROPLASTY AND APPROXIMATELY 10 MONTHS LATER WAS REVISED DUE TO DISSOCIATION OF THE HUMERAL INSERT FROM THE HUMERAL STEM. THE PREVIOUS HUMERAL INSERT WAS REPLACED WITH A +12 SPACER AND 36+0 INSERT. THE PATIENT REPORTED AN EVENT PUSHING A SHOPPING CART 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 15685201 ↗
• 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 ↗
• InjuryAug 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL THAT MAY HAVE CAUSED A DISSOCIATION. THE PATIENT UNDERWENT REVISION 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 15323369 ↗
• InjuryAug 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL THAT MAY HAE CAUSED A DISSOCIATION. THE PATIENT UNDERWENT REVISION 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 15323366 ↗
• 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 ↗
• InjuryApr 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS PLAYING BASKETBALL AND HAD 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 APPROXIMATELY 05 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 14074918 ↗