Comprehensive® Vivacit-E® 110031428Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00887868231599), received between Apr 27, 2022 and Aug 18, 2025 — classified as 10 injuries, 4 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• 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 22832415 ↗
• 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 22828436 ↗
• 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 19960150 ↗
• 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 19593784 ↗
• 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 19116317 ↗
• InjuryAug 28, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17632367 ↗
• InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 17596599 ↗
• 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 16460223 ↗
• MalfunctionSep 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS UNDERGOING AN INITIAL SHOULDER ARTHROPLASTY. DURING IMPLANTATION OF THE FIRST IMPLANT, THE POLYETHYLENE DISASSOCIATED AND WAS EXPLANTED. A SECOND POLYETHYLENE IMPLANT WAS USED AND THIS IMPLANT DISASSOCIATED AS WELL. A THIRD POLYETHYLENE IMPLANT WAS IMPLANTED AND IT WAS IMPLANTED SUCCESSFULLY. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.

  Patient problems: Failure of Implant

  MAUDE report 15458142 ↗
• MalfunctionSep 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY BEFORE IMPLANTATION IT WAS FOUND THAT THE HUMERAL BEARING POLY WAS SHIFTING ROUGHLY 1-3 MM IN EITHER DIRECTION. THE BEARING WAS THEN DISASSOCIATE FROM THE HUMERAL TRAY WITH THE SURGEON'S HANDS, AND THE HUMERAL BEARING BROKE OFF. THE SURGEON THEN PROCEEDED TO TRY ANOTHER POLY. IT DID THE EXACT SAME THING, EXCEPT THE TABS DID NOT BREAK ON THE SECOND POLY. WE THEN TRIED A THIRD 40 +3 POLY WHICH DID THE EXACT SOME THING AS THE PREVIOUS TWO, EXCEPT THE DOCTOR LEFT THE BEARING IN THE PATIENT AND FINISHED THE CASE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373290 ↗
• MalfunctionSep 7, 2022Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY BEFORE IMPLANTATION IT WAS FOUND THAT THE HUMERAL BEARING POLY WAS SHIFTING ROUGHLY 1-3MM IN EITHER DIRECTION. THE BEARING WAS THEN DISASSOCIATE FROM THE HUMERAL TRAY WITH THE SURGEON'S HANDS, AND THE HUMERAL BEARING BROKE OFF. THE SURGRON THEN PROCEEDED TO TRY ANOTHER POLY. IT DID THE EXACT SAME THING, EXCEPT THE TABS DID NOT BREAK ON THE SECOND POLY. WE THEN TRIED A THIRD 40 +3 POLY WHICH DID THE EXACT SOME THING AS THE PREVIOUS TWO, EXCEPT THE DOCTOR LEFT THE BEARING IN THE PATIENT AND FINISHED THE CASE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373280 ↗
• MalfunctionSep 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGERY BEFORE IMPLANTATION IT WAS FOUND THAT THE HUMERAL BEARING POLY WAS SHIFTING ROUGHLY 1-3MM IN EITHER DIRECTION. THE BEARING WAS THEN DISASSOCIATE FROM THE HUMERAL TRAY WITH THE SURGEON'S HANDS, AND THE HUMERAL BEARING BROKE OFF. THE SURGEON THEN PROCEEDED TO TRY ANOTHER POLY. IT DID THE EXACT SAME THING, EXCEPT THE TABS DID NOT BREAK ON THE SECOND POLY. WE THEN TRIED A THIRD 40 +3 POLY WHICH DID THE EXACT SOME THING AS THE PREVIOUS TWO, EXCEPT THE DOCTOR LEFT THE BEARING IN THE PATIENT AND FINISHED THE CASE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373259 ↗
• InjuryJul 27, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT HAD AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, ABOUT 2 WEEKS AGO THE PATIENT WAS REVISED DUE TO THE GLENOSPHERE BEING DISLOCATED. IT WAS STATED THAT THERE IS ALSO SIGNIFICANT WEAR ON THE HUMERAL POLY.

  Patient problems: Joint Dislocation

  MAUDE report 15114613 ↗
• InjuryApr 27, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; 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 14218526 ↗