Comprehensive® 110031403Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887868231353), received between May 5, 2021 and Aug 12, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated3
- Fracture1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Joint Dislocation3
- Failure of Implant2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2024Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information
IT WAS REPORTED THAT THE GLENOSPHERE, BEARING AND TRAY WERE REVISED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 19960152 ↗InjuryJul 22, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 19800415 ↗InjuryMar 9, 2023Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component
IT WAS REPORTED PATIENT UNDERWENT RIGHT SHOULDER REVISION DUE TO INSTABILITY. DURING THE PROCEDURE, THE HUMERAL BEARING WAS DISASSOCIATED WITH THE HUMERAL TRAY. THE BEARING, HUMERAL TRAY AND GLENOSPHERE WERE REMOVED AND REPLACED. NO PIECES WERE RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16517305 ↗InjuryFeb 15, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO BEARING DISASSOCIATING FROM THE TRAY. IT WAS NOTED THAT THREE LOCKING TABS WERE BROKEN OFF OF THE TRAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 16378032 ↗InjuryMay 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO THE POLY DISASSOCIATING FROM THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11776444 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.