Comprehensive Vivacit-ERecalls & reported problems across all models
Zimmer, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 93
- Deaths reported
- 1
- Injuries reported
- 85
- Recalls
- 0
We found 6 models of Comprehensive Vivacit-E by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Jan 7, 2020 and Sep 30, 2026 — classified as 1 death, 85 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (49 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Comprehensive Vivacit-E problems
Device problems
- Device Dislodged or Dislocated49
- Detachment of Device or Device Component23
- Adverse Event Without Identified Device or Use Problem14
- Unstable6
- Difficult to Insert3
- Mechanical Jam3
- Insufficient Device Problem Information2
- Noise, Audible2
Patient problems
- Joint Dislocation52
- Failure of Implant14
- Pain12
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions10
- Joint Impingement5
- Joint Laxity5
- Loss of Range of Motion4
Comprehensive Vivacit-E models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comprehensive® Vivacit-E® 110031424shoulder prosthesis, reverse configuration1 death44 reports
- Comprehensive® Vivacit-E® 110031427prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented17 reports
- Comprehensive® Vivacit-E® 110031428prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented14 reports
- Comprehensive® Vivacit-E® 110031425shoulder prosthesis, reverse configuration13 reports
- Comprehensive® Vivacit-E® 110031429shoulder prosthesis, reverse configuration4 reports
- Comprehensive® Vivacit-E® 110031426prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented1 report
Recent Comprehensive Vivacit-E adverse event reports
The 15 most recent reports across all models, 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 ↗InjurySep 1, 2026Device Dislodged or Dislocated
It was reported that a revision reverse total shoulder arthroplasty was performed on the left shoulder due to dislocation. The revision was performed seven weeks after implantation. The patient was unaware when or for how long the shoulder was dislocated. The humeral tray and bearing were explanted, and the bearing was upsized to provide additional stability. It was reported that no further information is available.
Patient problems: Joint Dislocation
MAUDE report 50538907 ↗InjuryJul 31, 2026Detachment of Device or Device Component
It was reported that the patient underwent an initial implantation on an unknown date. Subsequently, the patient was revised approximately nineteen (19) months ago due to disassociation of the poly bearing from the tray. Attempts have been made and no further information has been provided.
Patient problems: Crepitus; Insufficient Information
MAUDE report 50096878 ↗InjuryJul 14, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE POLYETHYLENE LINER DISSOCIATED FROM THE HUMERAL TRAY APPROXIMATELY THREE MONTHS POST-IMPLANTATION. THE PATIENT WAS REVISED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25812411 ↗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 ↗InjuryJun 15, 2026Detachment of Device or Device Component
IT WAS REPORTED THE PATIENT EXPERIENCED EARLY DISLOCATIONS FOLLOWING AN INITIAL SHOULDER ARTHROPLASTY AND SUBSEQUENTLY UNDERWENT A REVISION APPROXIMATELY 12 MONTHS POST-IMPLANTATION DUE TO CONTINUED INSTABILITY AND DISLOCATION. APPROXIMATELY 1 MONTH POST-IMPLANTATION AND AGAIN APPROXIMATELY 2 MONTHS POST-IMPLANTATION, THE SHOULDER DISLOCATED AND WAS MANAGED WITH CLOSED REDUCTIONS. INSTABILITY PERSISTED. AT REVISION EXPOSURE, THE HUMERAL BEARING WAS NOTED TO HAVE COME OFF THE HUMERAL TRAY. THE HUMERAL TRAY/BEARING AND THE GLENOSPHERE WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25503866 ↗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 25427697 ↗InjuryJun 2, 2026Device Dislodged or Dislocated
IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT A PREVIOUS REVISION DUE TO IMPINGEMENT AND DISLOCATION WHERE STANDARD IMPLANTS WERE USED. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A CUSTOM PMI PRODUCT ON AN UNKNOWN DAY TO REVISE THE GLENOSPHERE DUE TO JOINT LAXITY AND IMPINGEMENT ON THE ANTERIOR EDGE OF THE VRS BASEPLATE, CAUSING INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement; Joint Laxity
MAUDE report 25360085 ↗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 10, 2025Device 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 23767511 ↗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 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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