Comprehensive® 110031408Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868231407), received between Sep 1, 2023 and Jun 8, 2026 — classified as 2 injuries, 1 malfunction.
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. 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 Component2
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Aseptic loosening1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 MONTHS POST-IMPLANTATION DUE TO LOOSENING OF THE INLAY DESPITE ENGAGEMENT OF THE LOCKING MECHANISM. THE LOOSENING WAS NOTED DURING THE POSTOPERATIVE PERIOD. DURING THE REVISION PROCEDURE, INTRA-OPERATIVE ASSESSMENT CONFIRMED THE INLAY WAS LOOSE; THE SURGEON REVISED THE LOOSE INLAY AND RE-IMPLANTED THE INLAY COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening
MAUDE report 25427758 ↗InjuryOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 7 MONTHS POST-IMPLANTATION DUE TO LINER DISASSOCIATION. DURING FOLLOW-UP, LINER DISASSOCIATION WAS SUSPECTED AND A REVISION WAS SCHEDULED. INTRA-OPERATIVELY, THE LINER WAS FOUND LOOSE WITHIN THE CAPSULE AND WAS EASILY REMOVED WITH FORCEPS. THE TRAY WAS REMOVED AS WELL. THE GLENOSPHERE SHOWED NO APPARENT DAMAGE. TRIALING WAS PERFORMED WITH A +0 LINER, AFTER WHICH A +3 LINER WAS REQUESTED FOR RE-IMPLANTATION, AND THE WOUND WAS CLOSED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23295259 ↗MalfunctionSep 1, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT A FOREIGN SUBSTANCE WAS FOUND ON THE IMPLANT WHEN THE SURGEON ASSEMBLED THE LAST BEARING DURING A COMPREHENSIVE REVERSE TOTAL SHOULDER. THEY DIDN¿T USE THIS PRODUCT AND USED OTHER PRODUCTS TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17669193 ↗
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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