Comprehensive® 110031400Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887868231322), received between Mar 26, 2021 and Dec 10, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 Component4
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Joint Dislocation3
- Failure of Implant2
- Bone Fracture(s)1
- Implant Pain1
- Joint Laxity1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 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 Laxity
MAUDE report 23769759 ↗InjuryJul 25, 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: Implant Pain; Pain
MAUDE report 22621109 ↗InjuryJun 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 17040663 ↗InjuryMay 4, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE CAUSING THE PATIENT'S SHOULDER TO DISLOCATE.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 14280023 ↗InjuryFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINE (9) WEEKS LATER DUE TO DISASSOCIATION OF THE IMPLANTS.
Patient problems: Failure of Implant
MAUDE report 13497702 ↗InjuryMar 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED PATIENT UNDERWENT A LEFT SHOULDER REVISION SURGERY APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO DISLOCATION. DURING SURGERY IT WAS DISCOVERED THAT THE POLY INSERT WAS FREE FLOATING, AND NO LONGER ATTACHED TO THE TRAY. THE TRAY AND LINER COMPONENTS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 11575036 ↗
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.