Comprehensive® Reverse Shoulder 115394Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00880304677067), received between Nov 26, 2019 and Dec 18, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY REVERSE SHOULDER PROCEDURE. SUBSEQUENTLY, APPROXIMATELY 5 MONTHS AND 19 DAYS POST IMPLANTATION THE PATIENT WAS PRESENTING WITH A PAINFUL SHOULDER AND AN X-RAY AND CT SCAN SHOWED GLENOID COMPONENT MIGRATION. IT WAS NOTED THAT THE PATIENT HAD PRIOR NEUROLOGIC PATHOLOGY AND POOR BONE QUALITY. THE PATIENT PLANS TO BE REVISED WHERE THE GLENOID COMPONENTS WILL BE REMOVED WHILE DISCUSSING FURTHER OPTIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23843692 ↗
• InjuryDec 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23687853 ↗
• InjuryJul 16, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) YEAR AND SIX (6) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE (1) MONTH AGO DUE TO THE IMPLANTS LOOSENING. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 22524269 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY 5.5 YEARS AGO. THE PATIENT DID VERY WELL THROUGHOUT THE STUDY UNTIL REPORTING SEVERE PAIN AND INSTABILITY WITH ACTIVITIES AT THE 5 YEAR FOLLOW UP. NO TREATMENT OR INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 21734204 ↗
• InjuryFeb 12, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A LOOSENING OF THE DEVICE. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21370135 ↗
• InjuryNov 1, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. IT WAS ALSO REPORTED THAT AN UNKNOWN AMOUNT OF SCREWS WERE LOOSE FROM THE BASE PLATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20587274 ↗
• InjurySep 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BASEPLATE LOOSENING FROM THE GLENOID FOLLOWING AN INITIAL ARTHROSCOPY PROCEDURE. THE SURGEON INDICATED THE PATIENT'S ANATOMY, WITH VERY LITTLE BONE IN THE GLENOID, LIKELY CAUSED THE FAILURE. IMAGING CONFIRMED THIS LOOSENING APPROXIMATELY FIFTEEN (15) MONTHS LATER. ADDITIONALLY, ONE (1) OF THE PERIPHERAL SCREWS WAS FOUND TO BE FRACTURED DURING RADIOGRAPH EVALUATION. A FUTURE REVISION IS PLANNED ON AN UNKNOWN DATE. NO OTHER INTERVENTIONS OR HARMS HAVE BEEN REPORTED DUE TO THIS EVENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20321550 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS PRESCRIBED PAIN MEDICATION APPROXIMATELY 2.5 YEARS POST IMPLANTATION OF AN RTSA DUE TO CHRONIC SHOULDER PAIN. ALL DEVICES REMAIN IMPLANTED AND NO FURTHER INTERVENTION HAS OCCURRED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 19035593 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY APPROXIMATELY A YEAR AGO. SUBSEQUENTLY, THE PATIENT HAD A REVISION ABOUT 2 MONTHS LATER DUE TO A POST OPERATIVE INFECTION AND A 2 STAGE ANTIBIOTIC SPACER PLACEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 9700185 ↗
• InjuryNov 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS GLENOID IMPLANT RELATED BONE LOSS. SUBSEQUENT XRAYS SHOW GLENOSPHERE BASEPLATE HAS PULLED AWAY FROM BONE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: Erosion

  MAUDE report 9376292 ↗