Comprehensive® Vivacit-E® 110031429Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Comprehensive Vivacit-E (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868231605), received between Mar 5, 2024 and Feb 25, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Unstable2
- Detachment of Device or Device Component1
Patient problems
- Joint Dislocation2
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAS TO UNDERWENT ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 21465538 ↗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 21145332 ↗InjuryJul 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 MONTHS POST IMPLANATION DUE TO DISLOCATION. THE GLENOSPHERE, STEM, BEARING, AND TRAY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 19644521 ↗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 18836032 ↗
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 13, 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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