Comprehensive® Versa-Dial® 110030777Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00887868231261), received between Dec 14, 2020 and Dec 2, 2025 — classified as 14 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY APPROXIMATELY SIX (6) YEARS AND ONE (1) MONTH AGO. THE PATIENT HAS HAD A HISTORY OF MULTIPLE SHOULDER REVISIONS SURGERIES. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SIX (6) MONTHS AGO DUE TO IMPLANT DISLOCATION. DURING THE REVISION SURGERY THE SURGEON DISCOVERED THAT THE SCREWS WERE FRACTURED AND METALLOSIS. THERE WERE NO SIGNS OF INFECTION, ALTHOUGH THE SURGEON PERFORMED INFECTION WORKUP.

  Patient problems: Failure of Implant; Foreign Body In Patient; Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 21396886 ↗
• InjuryJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS FURTHER DISCOVERED THAT THE FRACTURE WAS THE PRIMARY ISSUE OF THE EVENT, AND THE DISLOCATION WAS SECONDARY. THIS COMPLAINT WILL BE ASSESSED FOR BONE FRACTURE. THE BEARING AND GLENOSPHERE WILL BE VOIDED AS THEY DID NOT CONTRIBUTE TO THE REPORTED EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 19593770 ↗
• InjuryMar 5, 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 SHOULDER ARTHROPLASTY APPROXIMATELY A LITTLE OVER ONE (1) MONTH AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION SEVENTEEN (17) DAYS LATER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 18836049 ↗
• InjurySep 28, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY EIGHT MONTHS AGO WITH A PRIMARY TSA SHOULDER SYSTEM. SUBSEQUENTLY, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION SURGERY APPROXIMATELY THREE (3) MONTHS LATER DUE TO REOCCURRING DISLOCATIONS OF THE IMPLANTS THAT CAUSED INSTABILITY OF THE SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 17834609 ↗
• InjuryJun 23, 2023Device 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 17189682 ↗
• InjuryApr 20, 2023Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SHOULDER REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 16779757 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO (2) AND A HALF MONTHS LATER DUE TO POST OPERATIVE DRAINAGE, A HEMATOMA, AND BLEEDING IN THE SHOULDER JOINT. THERE WERE NO SIGNS OF AN INFECTION AS THE PATIENT'S WHITE BLOOD CELL COUNT WAS NOT FOUND INTRAOPERATIVE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16460231 ↗
• InjuryJun 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION DUE TO DISLOCATION CAUSED BY DISASSOCIATION OF THE POLY BEARING AND TRAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation; Muscle Weakness/Atrophy

  MAUDE report 14713519 ↗
• InjuryFeb 18, 2022Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY SEVEN MONTHS POST IMPLANTATION DUE TO PAIN AND DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE OF THEIR LEFT SHOULDER. A NEW AUGMENTED BASEPLATE, GLENOSPHERE/TRAY/POLY WERE IMPLANTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 13560497 ↗
• InjuryDec 16, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 11020414 ↗
• InjuryDec 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 11003414 ↗