Comprehensive® Vivacit-E® 110031424Recalls & 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
Quick summary
This Zimmer Comprehensive Vivacit-E shoulder implant, used in reverse configuration shoulder replacement, appears in 43 adverse event reports, including 1 death and 40 injuries. Most reports describe the shoulder joint coming apart or dislocation after surgery, along with pain, looseness of the joint, and parts separating from the baseplate, sometimes after a fall and often requiring revision surgery to replace or remove components. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 1
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00887868231551), received between Jan 7, 2020 and Sep 30, 2026 — classified as 1 death, 41 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 Dislocated22
- Detachment of Device or Device Component11
- Adverse Event Without Identified Device or Use Problem9
- Unstable2
- Device Contaminated During Manufacture or Shipping1
- Malposition of Device1
- Material Erosion1
- Mechanical Jam1
Patient problems
- Joint Dislocation25
- Pain8
- Failure of Implant7
- No Clinical Signs, Symptoms or Conditions5
- Joint Laxity4
- Insufficient Information3
- Bone Fracture(s)2
- Discomfort2
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Dislodged or Dislocated
It was reported the patient underwent a revision approximately 7.5 weeks post-implantation due to instability/dislocation. Radiographs demonstrated the stem in varus alignment. Attempts have been made and no further information has been provided.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 50948453 ↗InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS BEING CONSIDERED FOR A REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25588362 ↗InjuryMay 27, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISLOCATION. THE BASEPLATE, TRAY AND BEARING WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 25306957 ↗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 25133783 ↗InjuryMar 9, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A BEARING EXCHANGE WAS PERFORMED ON THE SHOULDER APPROXIMATELY THREE AND A HALF (3.5) MONTHS POST-IMPLANTATION DUE TO DISLOCATION ATTRIBUTED TO A FALL. DURING THE REVISION PROCEDURE, THE CENTRAL SCREW WAS TIGHTENED, THE SHOULDER WAS ASSESSED FOR BONEY IMPINGEMENT, AND THE GLENOSPHERE WAS RE-IMPLANTED WITHOUT REVISION. NO ADDITIONAL HARM FROM THE EVENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24545372 ↗InjuryFeb 23, 2026Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 24414143 ↗InjuryJan 23, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24161865 ↗InjuryDec 9, 2025Detachment 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: Fall; Joint Dislocation
MAUDE report 23760485 ↗InjuryNov 13, 2025Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Impingement; Pain
MAUDE report 23544135 ↗MalfunctionSep 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING A PROCEDURE, THE PACKAGING WAS OPENED AND DISCOVERED THAT THERE WAS A HAIR FOUND ON THE BEARING. THERE WAS APPROXIMATELY A 5 MINUTE DELAY WHILE ANOTHER IMPLANT WAS PREPARED TO BE USED. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22998419 ↗InjuryAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT WAS FOUND TO HAVE A DISLOCATED SHOULDER IMPLANT DURING POST-OP VISIT. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY TWO MONTHS POST-OP. NO ADDITIONAL COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 22738028 ↗InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT HAD A PRIMARY SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY 3 YEARS LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A DISLOCATION. THE HUMERAL HEAD AND GLENOID COMPONENTS WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 22663300 ↗InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT A SHOULDER REVISION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Laxity
MAUDE report 22565231 ↗DeathJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN RECOVERY FOLLOWING A REVERSE TOTAL SHOULDER REPLACEMENT WITH THE COMPREHENSIVE SYSTEM. AS FAR AS THE SURGEON WAS CONCERNED, THE OPERATION WAS COMPLETED AS EXPECTED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22531163 ↗InjuryJun 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION APPROXIMATELY ONE (1) YEAR AND SIX (6) MONTHS POST-IMPLANTATION DUE TO EXPERIENCING JOINT DISLOCATION AND INSTABILITY. DURING THE REVISION, THE HUMERAL TRAY, POLY, AND GLENOSPHERE WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 22283631 ↗InjuryMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 21946007 ↗InjuryMar 31, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY. DURING THE SURGERY THE PATIENT WAS INJURED DUE TO AN UNKNOWN FAILURE OF THE IMPLANT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Insufficient Information; Joint Dislocation
MAUDE report 21730968 ↗InjuryMar 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21605382 ↗InjuryJan 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOUR MONTHS POST INITIAL IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOSPHERE. DURING REVISION, THE CENTRAL SCREW WAS FOUND TO BE INSUFFICIENTLY SEATED AND WAS REVISED. EXTRA BONY OSTEOPHYTES WERE CLEARED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Joint Dislocation
MAUDE report 21147911 ↗InjuryJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT, ON AN UNKNOWN DATE, BEGAN TO EXPERIENCE PAIN AND A CRUNCHING SOUND AFTER LAYING DOWN AND ROLLING OVER. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR (4) MONTHS AGO DUE TO THE IMPLANTS DISASSOCIATING. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 21111964 ↗InjuryJan 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT WAS REVISED TWO WEEKS POST-INITIAL IMPLANTATION DUE TO HEAD DISLOCATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Joint Dislocation
MAUDE report 21102351 ↗InjuryNov 12, 2024Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY NINE (9) MONTHS AGO. THE PATIENT ON AND UNKNOWN DATE PRESENTED WITH A DISLOCATED SHOULDER THAT WAS REDUCED. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY ONE (1) MONTH AGO DUE TO INSTABILITY AND AN AUDIBLE CLUNK. THE SURGEON NOTED THAT THE BEARING HAD DISASSOCIATED FROM THE TRAY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 20664944 ↗InjuryNov 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT OUTSIDE OF SURGERY THE SAME DAY OF THE SURGERY, THAT THE SHOULDER WAS DISLOCATED. THE SURGEON MANUALLY CORRECTED THE DISLOCATION THE SAME DAY AS THE INITIAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 20609836 ↗InjuryJul 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 19700277 ↗InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY THREE (3) YEARS AND FIVE (5) AND A HALF MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AGO DUE TO PAIN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 19498545 ↗
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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