Comprehensive® Versa-Dial® 110030776Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887868231254), received between Jun 17, 2020 and Sep 21, 2026 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, 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 ↗
• 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

  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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: Joint Dislocation

  MAUDE report 20878645 ↗
• InjuryAug 12, 2024Device Dislodged or Dislocated; Insufficient Device Problem Information; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE GLENOSPHERE, BEARING AND TRAY WERE REVISED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 19960141 ↗
• 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 19644522 ↗
• InjuryJun 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 19459861 ↗
• InjuryMay 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 16876489 ↗
• InjuryDec 2, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION DUE TO DISCOMFORT AND CLICKING OF IMPLANTS.

  Patient problems: Discomfort

  MAUDE report 15904375 ↗
• InjuryOct 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 1 MONTH 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 15536561 ↗
• InjurySep 21, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 MONTHS POSTIMPLANTATION DUE TO IMPINGEMENT OF THE GLENOSPHERE AND CUSTOM GLENOID. GLENOSPHERE AND VRS WERE REMOVED AND THE TRAY AND BEARING SWAPPED WITH A VERSADIAL HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461457 ↗
• InjuryFeb 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINE (9) WEEKS LATER DUE TO DISASSOCIATION OF THE IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 13497671 ↗
• MalfunctionJun 17, 2020Malposition of Device; Scratched Material; Noise, Audible; Malposition of Device; Scratched Material; Noise, Audible

  IT WAS REPORTED THAT PATIENT UNDER WENT RIGHT REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) MONTHS AGO. SUBSEQUENTLY, THE POLY BEARING DISASSOCIATED FROM THE TRAY AND PATIENT WAS REVISED APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION. THE BEARING, TRAY, AND GLENOSPHERE WERE REMOVED AND REPLACED. THE GLENOSPHERE WAS FOUND TO HAVE BEEN MALPOSITIONED AND WAS SCRATCHED.

  Patient problems: Pain

  MAUDE report 10162432 ↗