COMPREHENSIVE® REVERSE SHOULDER 110032410Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00880304993235), received between Jul 27, 2021 and Sep 21, 2026 — classified as 1 death, 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K172502); they may or may not involve this specific model.

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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Difficult to Insert

  It was reported that during a procedure, the mini taper was unable to be engaged into the 40mm glenosphere. It was noted that the taper sat proud event after impacting. The surgeon reverted to using a 36mm glenosphere instead and used a new taper with it successfully. There was a 15 minute delay to the case but no other patient consequences were reported as a result of the event. Attempts have been made and no further information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838805 ↗
• InjuryAug 18, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent a revision due to loosening. Attempts have been made, and no further information has been provided.

  Patient problems: Aseptic loosening

  MAUDE report 50303092 ↗
• InjuryJun 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 12 DAYS POST IMPLANTATION DUE TO DISASSOCIATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25610159 ↗
• InjuryApr 1, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 DAYS POST IMPLANTATION DUE TO A POORLY FIXATED AND LOOSENED CENTRAL SCREW. THE SURGEON STATED THE CENTRAL SCREW WAS TOO SHORT AND NOT BICORTICAL, AND ACCEPTED THIS AS SURGEON ERROR. THE SURGEON ALSO REPORTED THE PATIENT HAD POOR BONE QUALITY AND AVASCULAR NECROSIS, WHICH MAY HAVE CONTRIBUTED TO THE FAILURE, AND WAS UNSURE IF A LONGER BICORTICAL CENTRAL SCREW WOULD HAVE PREVENTED THE LOOSENING FAILURE. THE PATIENT WAS REVISED BY REMOVING THE GLENOID/BASEPLATE AND CONVERTING TO A HEMIARTHROPLASTY. THE HUMERAL STEM REMAINED IN SITU. NO ADDITIONAL PATIENT OUTCOME INFORMATION WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24757190 ↗
• InjuryNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Pain

  MAUDE report 23657619 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bone Notching; Pain

  MAUDE report 23639436 ↗
• InjuryNov 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT EXPERIENCED ANOTHER GLENOSPHERE DISASSOCIATION APPROXIMATELY FOUR YEARS AFTER THE LAST REVISION SURGERY. THE PATIENT HAD A HISTORY OF PRIOR REVISION SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. APPROXIMATELY FOUR YEARS AFTER THAT PRIOR REVISION, THE GLENOSPHERE AGAIN DISASSOCIATED. THE PATIENT SUBSEQUENTLY UNDERWENT REVISION SURGERY, AND THE AFFECTED COMPONENTS WERE EXPLANTED APPROXIMATELY 3 YEARS AND 10 MONTHS POST IMPLANTATION. NO INFORMATION WAS PROVIDED REGARDING INTRA-OPERATIVE FINDINGS OR ENVIRONMENTAL FACTORS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511452 ↗
• InjuryOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 23391319 ↗
• InjuryOct 17, 2025Malposition of Device; Malposition of Device

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

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321498 ↗
• DeathJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN RECOVERY FOLLOWING A REVERSE TOTAL SHOULDER REPLACEMENT WITH THE COMPREHENSIVE SYSTEM. AS FAR AS THE SURGEON WAS CONCERNED, THE OPERATION WAS COMPLETED AS EXPECTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22530348 ↗
• InjuryJun 18, 2025Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth; Material Erosion; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT TOTAL ANATOMICAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCTS. APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO, THE PATIENT WAS REVISED TO A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO GLENOID LOOSENING AND FAILED ROTATOR CUFF. SUBSEQUENTLY, THE PATIENT HAD FALLEN APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS POST-IMPLANTATION AND THEN BEGAN TO HAVE PAIN. RADIOGRAPHIC IMAGING DISPLAYED MALALIGNMENT OF THE GLENOSPHERE, FRACTURED SCREW, LUCENCY AROUND THE INFERIOR LOCKING SCREW, RADIO-DENSE BODIES SUPERIOR IN THE JOINT, AND LIKELY BONY FRAGMENTS INFERIORLY. APPROXIMATELY ONE (1) MONTH AGO, THE PATIENT UNDERWENT A REVISION WHERE A LITTLE BIT OF METALLOSIS OF THE SOFT TISSUE AROUND THE JOINT CAPSULE WAS ENCOUNTERED AND THE CENTRAL SCREW WAS FRACTURED. CANCELLOUS ALLOGRAFT WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO A HEMIARTHROPLASTY WITH PLANS FOR A POSSIBLE REVISION IN THE FUTURE.

  Patient problems: Aseptic loosening; Metal Related Pathology; Pain; Radiolucent Lines

  MAUDE report 22285129 ↗
• 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 21734206 ↗
• InjuryMar 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Foreign Body In Patient; Joint Dislocation; Metal Related Pathology

  MAUDE report 21690069 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOUR MONTHS POST INITIAL IMPLANTATION DUE TO SCAPULAR FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 21504792 ↗
• InjuryNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION. DURING THE REVISION PROCEDURE, IT WAS OBSERVED THAT THE SCREW WAS NOT FULLY SEATED FROM THE INITIAL PROCEDURE. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERWENT ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20610955 ↗
• InjurySep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant

  MAUDE report 20135715 ↗
• InjuryAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant

  MAUDE report 19981246 ↗
• InjuryJul 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 19852143 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE UNDERWENT A RIGHT SHOULDER REPLACEMENT APPROXIMATELY 2 MONTHS AGO. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM AND IMAGING REVEALED THAT THE BASEPLATE, SCREWS, AND GLENOSPHERE HAD MIGRATED OUT OF THE PATIENT'S GLENOID, SECONDARY TO FRACTURE. THE SURGEON INDICATED THE FRACTURE LIKELY WAS FROM THE PRIMARY PROCEDURE. THEREFORE, THE PATIENT WAS REVISED APPROXIMATELY 3 WEEKS AGO DUE TO A BONE FRACTURE. THE HUMERAL STEM, HUMERAL TRAY, AND HUMERAL BEARING REMAINED IN SITU. THE SURGEON DEEMED THE GLENOID TO BE UNSALVAGEABLE DUE TO THE FRACTURE. THEREFORE, THE SURGEON PACKED THE GLENOID WITH SYNTHETIC BONE GRAFT AND USED A MINI HUMERAL TRAY AND BEARING WITH AN OVERSIZED HUMERAL HEAD FOR SALVAGE HEMI-ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 19643193 ↗
• InjuryMay 21, 2024Fracture; Fracture

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

  Patient problems: Bacterial Infection; Failure of Implant; Pain

  MAUDE report 19358858 ↗
• InjuryApr 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN, DISLOCATION AND GLENOID BONE FRACTURE. THE PATIENT WAS REVISED APPROXIMATELY THREE WEEKS POST IMPLANTATION AFTER A FAILED MANIPULATION UNDER ANESTHESIA. A CEMENT SPACER WAS IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 19096505 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A PROCEDURE APPROXIMATELY 4 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ABOUT A MONTH AGO DUE TO PAIN, REACTIVE TISSUE, FLUID IN THE CAPSULE, AND TISSUE BETWEEN THE BASEPLATE AND GLENOSPHERE. THERE IS POSSIBLE METALLOSIS OR ALLERGY. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain

  MAUDE report 17643707 ↗
• MalfunctionMay 15, 2023Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929154 ↗
• InjuryMar 2, 2023Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY. APPROXIMATELY 1 MONTH POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, SCAPULAR NOTCHING, AND DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE AS NOTED ON X-RAY. DURING THE REVISION, SEVERE METALLOSIS WAS NOTED THROUGHOUT THE JOINT DUE TO SEVERE WEAR OF THE POLY AND BASEPLATE AS WELL AS THE DISLOCATION AND DISASSOCIATION. SIGNIFICANT BONE LOSS AND EROSION WERE ALSO NOTED. THE STEM WAS LEFT INTACT, AND THE GLENOID WAS CONVERTED TO A HEMIARTHROPLASTY WITH A NEW HEAD AND TAPER PLACED.

  Patient problems: Erosion; Failure of Implant; Joint Dislocation; Metal Related Pathology; Osteopenia/ Osteoporosis; Pain

  MAUDE report 16474082 ↗
• InjuryFeb 14, 2023Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth; Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AGO. THEN, ABOUT FIVE (5) MONTHS LATER THE PATIENT REPORTED PAIN. COMPUTERIZED TOMOGRAPHY (CT) AND RADIOGRAPHS REVEALED ACROMIAL STRESS FRACTURE HEALING, SUPERIOR TILT, SCAPULAR NOTCHING, LOOSENING OF THE BASEPLATE, AND FAILURE OF THE REVERSE BASEPLATE. TWO MONTHS LATER, AN ASPIRATION WAS CONDUCTED AND RULED OUT INFECTION. A 2-STAGE REVISION WAS PLANNED TO PLACE SPACERS TO OBTAIN PROPER IMAGING FOR IMPLANTS OF WORN GLENOID. SUBSEQUENTLY THE FIRST STAGE REVISION WAS DELAYED DUE TO PATIENT. CONSEQUENTLY, FOUR (4) MONTHS LATER THE 1ST STAGE REVISION WAS CONDUCTED, AND THE SURGEON NOTED THE STEM WAS WELL FIXED AND THE SURGEON OPTED TO KEEP THE STEM IMPLANTED. THEREFORE, THE SURGEON SWITCHED THE REVISION TO A HEMIARTHROPLASTY WITHOUT SPACERS. THE GLENOID WAS LOOSE AND EXCHANGED. THEN, ABOUT FIVE (5) MONTHS LATER THE 2ND STAGE REVISION OF HEMIARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY WAS COMPLETED. NO OPERATIVE RECORDS PROVIDED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Bone Fracture(s); Erosion; Failure of Implant; Pain

  MAUDE report 16370955 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172502. One submission often covers many models, so check the product and lot details in each record.

• Z-0520-2020 · Aug 21, 2019 · Terminated
  COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM5