Comprehensive Versa-DialRecalls & reported problems across all models
Zimmer, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls
- 0
We found 3 models of Comprehensive Versa-Dial by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between Jun 17, 2020 and Sep 21, 2026 — classified as 40 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 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 Versa-Dial problems
Device problems
- Device Dislodged or Dislocated27
- Adverse Event Without Identified Device or Use Problem9
- Detachment of Device or Device Component3
- Mechanical Jam2
- Noise, Audible2
- Unintended Movement2
- Difficult to Insert1
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation25
- Failure of Implant9
- Joint Impingement7
- Insufficient Information5
- Pain4
- Loss of Range of Motion3
- No Clinical Signs, Symptoms or Conditions3
- Metal Related Pathology2
Comprehensive Versa-Dial models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Comprehensive® Versa-Dial® 110030776prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented16 reports
- Comprehensive® Versa-Dial® 110030777PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED14 reports
- Comprehensive® Versa-Dial® 110030778PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED12 reports
Recent Comprehensive Versa-Dial adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Difficult to Insert
It was reported that during a procedure, the mini taper was unable to be engaged into the 40mm glenosphere. It was noted that the taper sat proud event after impacting. The surgeon reverted to using a 36mm glenosphere instead and used a new taper with it successfully. There was a 15 minute delay to the case but no other patient consequences were reported as a result of the event. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838868 ↗InjuryJun 16, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY ONE (1) YEAR AND ONE (1) MONTH POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY IMPINGEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 25519562 ↗InjuryMay 29, 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 25336710 ↗InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A REVERSE SHOULDER REVISION PROCEDURE APPROXIMATELY 5 MONTHS POST-IMPLANTATION DUE TO COMPONENT DISLOCATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23693715 ↗InjuryNov 14, 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 23555363 ↗InjuryAug 21, 2025Material Erosion; Device Dislodged or Dislocated; Material Erosion; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain; Subluxation
MAUDE report 22868398 ↗InjuryAug 18, 2025Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; Joint Impingement; Loss of Range of Motion
MAUDE report 22832474 ↗InjuryAug 18, 2025Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Mechanical Jam; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT THEN UNDERWENT MULTIPLE REVISION SURGERIES. SUBSEQUENTLY, THE PATIENT UNDERWENT A THIRD REVISION SURGERY APPROXIMATELY EIGHT (8) MONTHS AGO DO TO AN UNKNOWN REASON TO REVISE THE POLY AND TRAY. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Insufficient Information; Joint Impingement; Loss of Range of Motion
MAUDE report 22828437 ↗InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION SURGERY APPROXIMATELY THREE (3) MONTHS AGO. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO AN UNKNOWN REASON USING A CUSTOM GLENOSPHERE AND A CUSTOM BEARING. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT
Patient problems: Insufficient Information
MAUDE report 22608031 ↗InjuryJun 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE BEARING AND HUMERAL TRAY TO DISASSOCIATE, CAUSING THE GLENOSPHERE TO DISLOCATE FROM THE BEARING. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 22366893 ↗InjuryMay 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 21945171 ↗InjuryApr 29, 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 21928402 ↗InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT HAS HAD A HISTORY OF MULTIPLE REVISIONS OF THEIR RIGHT REVERSE TOTAL SHOULDER THAT WAS INITIALLY IMPLANTED APPROXIMATELY 6 YEARS AGO. AFTER RECEIVING A NEW REVERSE SHOULDER APPROXIMATELY 2 MONTHS AGO, THE PATIENT WAS REVISED AGAIN 1 MONTH AGO DUE TO DISLOCATION. THE BASEPLATE WAS RETAINED AND ALL OTHER COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 21645213 ↗InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT HAS HAD A HISTORY OF MULTIPLE REVISIONS OF A RIGHT REVERSE SHOULDER THAT WAS INITIALLY IMPLANTED APPROXIMATELY 6 YEARS AGO. THE MOST RECENT REVISION OCCURRED APPROXIMATELY 1 MONTH AGO, AND THE PATIENT WAS SCHEDULED TO HAVE ANOTHER REVISION DUE TO DISLOCATION APPROXIMATELY 2 WEEKS AGO; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 21642433 ↗InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 WEEKS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 21583314 ↗
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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