Comprehensive® Reverse Shoulder 110040210Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887868254536), received between May 1, 2023 and Jan 26, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON BROKE THE REAMER GUIDE BY GOING OFF AXIS. NO 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 24178163 ↗
• MalfunctionDec 29, 2025Fracture; Material Deformation; Mechanical Jam; Fracture; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT A SMALL AUGMENT REAMER GUIDE BECAME STUCK IN THE GLENOID DURING THE PROCEDURE. FOLLOWING A DIFFICULT REMOVAL, VISIBLE DAMAGE TO THE GUIDE WAS OBSERVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918631 ↗
• MalfunctionDec 15, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802597 ↗
• MalfunctionOct 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SMALL REAMER GUIDE BROKE WHILE MILLING THE BONE. IN RESPONSE, THE SURGEON USED A CURETTE TO REMOVE THE CARTILAGE AND PROCEEDED WITH THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THE REMAINDER OF THE OPERATION WAS COMPLETED SUCCESSFULLY. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23231957 ↗
• InjurySep 24, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

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

  Patient problems: Bone Fracture(s)

  MAUDE report 23137056 ↗
• MalfunctionMay 1, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843918 ↗

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