COMPREHENSIVE® REVERSE SHOULDER 110032430Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00880304993259), received between Jun 19, 2020 and Nov 18, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 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 23582944 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY USING A CUSTOM IMPLANT ON AND UNKNOWN DATE FOR AN UNKNOWN REASON. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 22911456 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT MATCH IMPLANT (PMI) GROUP THAT THE PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT DUE TO GLENOID FRACTURE/EROSION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Erosion

  MAUDE report 21961669 ↗
• InjuryJun 21, 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 PATIENT'S ANATOMY, WITH VERY LITTLE BONE IN THE GLENOID, WAS INDICATED BY THE SURGEON TO HAVE CAUSED THE FAILURE. IMAGING CONFIRMED THIS LOOSENING APPROXIMATELY FIFTEEN (15) MONTHS LATER. 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 19582106 ↗
• InjuryDec 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISASSOCIATION APPROXIMATELY FOUR YEARS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18364477 ↗
• InjuryOct 23, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING FLUID COLLECTION IN THE SHOULDER AND UNDERWENT A WASHOUT APPROXIMATELY TWO (2) MONTHS AGO. DURING THE WASHOUT, THE SURGEON NOTED METALLOSIS, WHICH WAS LATER CONFIRMED WITH A CULTURE TEST. THERE WAS ALSO NOTE OF BASEPLATE FAILURE. THE PATIENT LATER UNDERWENT A REVISION APPROXIMATELY THREE (3) WEEKS AGO TO REMOVE THE IMPLANTS. MEDICAL IMAGES WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL AND IDENTIFIED DISASSOCIATION OF THE BASEPLATE, IMPLANT FRACTURE, AND OSTEOPENIC BONE QUALITY.

  Patient problems: Failure of Implant; Metal Related Pathology; Osteopenia/ Osteoporosis; Synovitis

  MAUDE report 17985369 ↗
• InjurySep 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17728264 ↗
• InjuryJun 1, 2023Loosening 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

  MAUDE report 17037676 ↗
• InjuryMar 6, 2023Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY APPROXIMATELY 3 YEARS AGO, SUBSEQUENTLY THEY THEN HAD A REVISION FOR THE REMOVAL OF THE GLENOSPHERE IMPLANT AND BASEPLATE PULLOUT. DURING THE REVISION THERE WAS A BROKEN SCREW THAT WAS PARTIALLY REMOVED, HOWEVER SOME THE SCREW REMAINED IN THE GLENOID. ALSO, THE BACTERIOLOGY WAS POSITIVE FOR CUTI ACNES, BUT THERE WERE NO INTRAOPERATIVE SEPTIC SIGNS, NOR PAIN BEFORE THE BREAKAGE OF THE MATERIAL. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Bacterial Infection; Failure of Implant; Foreign Body In Patient

  MAUDE report 16487154 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPACTING THE IMPLANT WITH THE INSTRUMENT, THE PATIENT'S BONE WAS FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 16273209 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH POSTIMPLANTATION DUE TO UNKNOWN REASONS. THE TAPER ADAPTOR WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825411 ↗
• InjuryMar 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT IS BEING CONSIDERING FOR A REVISION AT AN UNKNOWN DATE DUE TO TOTAL FAILURE OF THE GLENOID COMPONENTS (BROKEN SCREWS AND BASEPLATE PULLED OUT FROM GLENOID). ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13758034 ↗
• InjuryDec 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 13060223 ↗
• InjuryJun 19, 2020Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

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

  Patient problems: No Code Available

  MAUDE report 10173939 ↗

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