Comprehensive® Vivacit-E® 110031427Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00887868231582), received between Feb 16, 2021 and Sep 1, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• InjuryDec 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A REVERSE SHOULDER REVISION PROCEDURE; APPROXIMATELY 2 MONTHS POST-IMPLANTATION DUE TO COMPONENT DISLOCATION. THE PATIENT ALSO EXPERIENCED PAIN DUE TO THE MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 23693747 ↗
• InjuryAug 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT HAD A SHOULDER REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE TWO DAYS POST IMPLANTATION DUE TO COMPONENT DISASSOCIATION. NO ADDITIONAL COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22823169 ↗
• InjuryJun 30, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; 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 22366888 ↗
• InjuryApr 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY TWENTY-EIGHT (28) DAYS AGO. SUBSEQUENTLY, THREE (3) DAYS AFTER THEIR INITIAL SURGERY THE PATIENT WAS REVISED DUE TO THE IMPLANTS DISLOCATING.

  Patient problems: Joint Dislocation

  MAUDE report 21928409 ↗
• InjuryDec 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: Joint Dislocation

  MAUDE report 20879926 ↗
• InjuryJul 22, 2024Detachment 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: Joint Dislocation

  MAUDE report 19799500 ↗
• InjuryMay 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A SHOULDER PROCEDURE ON APPROXIMATELY 3 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION 2 MONTHS LATER. THE PATIENT'S SOFT TISSUES ARE SEVERELY COMPROMISED, AND THE PATIENT DID NOT KEEP HIS SHOULDER IMMOBILIZED AS INSTRUCTED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 16876493 ↗
• 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 15904363 ↗
• 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 15536565 ↗
• InjurySep 16, 2021Device 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 12482819 ↗
• InjuryFeb 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation; Pain

  MAUDE report 11331778 ↗