Comprehensive® Versa-Dial® 110030778Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Comprehensive Versa-Dial (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00887868231278), received between Mar 19, 2022 and May 29, 2026 — classified as 12 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 Dislocated7
- Adverse Event Without Identified Device or Use Problem4
- Loosening of Implant Not Related to Bone-Ingrowth1
- Mechanical Jam1
Patient problems
- Joint Dislocation7
- Joint Impingement5
- Insufficient Information3
- Failure of Implant1
- Joint Laxity1
- Loss of Range of Motion1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 ↗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 ↗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 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO DUE TO INSTABILITY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION TO INCREASE CONSTRAINT ON AN UNKNOWN DATE. A CUSTOM IMPLANT REQUEST WAS SUBMITTED TO A COMPETITOR TO REPLACE ALL CURRENT IMPLANTS EXCEPT THE STEM AND GLENOID BASEPLATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20515482 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY NINE (9) MONTHS AFTER THE INITIAL IMPLANTATION TO RECEIVE A PMI DEVICE DUE TO CHRONIC DISLOCATION. IT WAS NOTED THE PATIENT HAD ALSO PREVIOUSLY UNDERWENT TWO PRIOR REVISIONS DUE TO EXPERIENCING DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116308 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PMI GROUP THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY THE HUMERAL COMPONENT COMING IN CONTACT WITH THE VRS. DURING THE PROCEDURE, THE POLY WAS EXCHANGED AND THE GLENOSPHERE AND VRS COMPONENTS REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116277 ↗InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT THEIR SECOND REVISION APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION DUE TO CHRONIC DISLOCATION CAUSED BY THE HUMERAL COMPONENT COMING IN CONTACT WITH THE VRS. DURING THIS PROCEDURE, THE POLY AND GLENOSPHERE WERE EXCHANGED AND THE VRS COMPONENT REMAINED IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation; Joint Impingement
MAUDE report 19116184 ↗InjuryJun 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 17037729 ↗InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH POSTIMPLANTATION DUE TO UNKNOWN REASONS. THE TRAY, BEARING, AND GLENOSPHERE WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13824914 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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