Comprehensive® 110031406Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868231384), received between Jun 23, 2023 and Jan 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL SHOULDER ON AN UNKNOWN DATE WITH UNKNOWN IMPLANTS. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE REVISIONS DUE TO INSTABILITY. SUBSEQUENTLY, APPROXIMATELY ONE (1) YEAR AND TEN (10) MONTHS AFTER THE LAST REVISION, THE PATIENT WAS REVISED FOR A FOURTH TIME DUE TO INSTABILITY AND POLY DISASSOCIATION. NO FURTHER DETAILS PROVIDED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21145334 ↗
• InjuryJun 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY THREE (3) WEEKS AGO DUE TO EXPERIENCING MULTIPLE POSSIBLE DISLOCATIONS. SUBSEQUENTLY, DURING THE REVISION IT WAS NOTED THAT THE HUMERAL BEARING COMPLETELY DISASSOCIATED FROM THE HUMERAL TRAY AND VISUAL INSPECTION OF THE BEARING NOTES DAMAGE OF THE BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 17189673 ↗