G7® Vivacit-E® 30103608Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024519930), received between Apr 5, 2021 and May 3, 2023 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY. A FEW DAYS LATER THE PATIENT UNDERWENT REPOSITIONING WITH ANESTHESIA DUE TO DISLOCATION. THE PATIENT DISLOCATED THEIR RIGHT HIP A SECOND AND THIRD TIME DUE TO UNKNOWN REASONS REQUIRING REPOSITIONING A MONTH AND FOUR MONTHS POST IMPLANTATION. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 16862680 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT INITIAL RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED. THE PATIENT UNDERWENT REPOSITIONING WITH ANESTHESIA DUE TO DISLOCATION APPROXIMATELY THREE (3) WEEKS LATER. THE PATIENT DISLOCATED FOR A SECOND TIME DUE TO UNKNOWN REASONS REQUIRING REPOSITIONING APPROXIMATELY TWO (2) WEEKS LATER. SUBSEQUENTLY THE PATIENT DISLOCATED THEIR HIP A THIRD TIME REQUIRING REPOSITIONING APPROXIMATELY THREE (3) MONTHS LATER. THERE HAVE BEEN NO ADDITIONAL COMPLICATIONS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16682961 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT INITIAL RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED. THE PATIENT UNDERWENT REPOSITIONING WITH ANESTHESIA DUE TO DISLOCATION APPROXIMATELY THREE (3) WEEKS LATER. THE PATIENT DISLOCATED FOR A SECOND TIME DUE TO UNKNOWN REASONS REQUIRING REPOSITIONING APPROXIMATELY TWO (2) WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16682955 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT INITIAL RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED. THE PATIENT UNDERWENT REPOSITIONING WITH ANESTHESIA DUE TO DISLOCATION APPROXIMATELY THREE (3) WEEKS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16682953 ↗
• InjuryDec 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO SUBLUXATION APPROXIMATELY 23 DAYS POST RIGHT TOTAL HIP ARTHROPLASTY. NO DEVICES WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Subluxation

  MAUDE report 16004262 ↗
• MalfunctionSep 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A RIGHT HIP PROCEDURE, THE SURGEON ATTEMPTED TO IMPLANT THE LINER MULTIPLES TIMES. EXAMINED THE LINER AND TRIED AGAIN. AFTER THE FINAL ATTEMPTED FAILED, A NEW IMPLANT WAS OPENED AND WAS IMPLANTED SUCCESSFULLY. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT. 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 15413697 ↗
• MalfunctionApr 5, 2021Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614556 ↗
• MalfunctionApr 5, 2021Positioning Failure; Positioning Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614530 ↗