Comprehensive® 110031401Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Comprehensive (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868231339), received between Mar 5, 2024 and May 10, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2026Detachment of Device or Device Component
UPDATED 10 MAY 2026: IT WAS REPORTED THAT THE GLENOSPHERE AND TAPER ADAPTER SEPARATED FROM THE BASEPLATE FOLLOWING AN INITIAL SHOULDER ARTHROPLASTY PROCEDURE, REQUIRING A REVISION APPROXIMATELY ONE (1) WEEK LATER. DURING THE REVISION PROCEDURE, THE CENTRAL SCREW WAS OBSERVED TO BE DOWN, AND IT WAS NOTED THAT SOFT TISSUE MAY HAVE PREVENTED THE GLENOSPHERE FROM PROPERLY ENGAGING THE TAPER, POSSIBLY DUE TO A FALL. THE REVISION PROCEDURE WAS SUCCESSFUL, AND NO ADDITIONAL HARM, SYMPTOMS, OR IMPACTS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133784 ↗InjuryMar 5, 2024Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY ONE MONTH POST-INITIAL IMPLANTATION DUE TO INSTABILITY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836034 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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