G7® Vivacit-E® 30123204Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024520424), received between Mar 31, 2022 and Apr 7, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-OP, THE PATIENT REPORTED MODERATE PAIN AND WAS DIAGNOSED WITH TROCHANTERIC BURSITIS AND GIVEN A CORTISONE INJECTION. A SECOND INJECTION WAS REQUIRED AT THE THREE-YEAR POST-OP FOLLOW UP DUE TO RECURRENT TROCHANTERIC BURSITIS AND PAIN. A THIRD INJECTION AND TOPICAL ANTI-INFLAMMATORY CREAM WAS GIVEN SIX-MONTHS LATER FOR MODERATE PAIN. ALL IMPLANTS REMAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Pain

  MAUDE report 21784992 ↗
• MalfunctionJun 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547936 ↗
• MalfunctionJun 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547932 ↗
• MalfunctionJun 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, THE POLYETHYLENE LINER WOULD NOT ASSEMBLE TO THE ACETABULAR SHELL. THE SURGEON USED A NEW LINER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475382 ↗
• MalfunctionSep 7, 2023Difficult to Insert; Difficult to Insert

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699157 ↗
• InjuryMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT EXPERIENCED A LEFT HIP DISLOCATION APPROXIMATELY ELEVEN YEARS POST IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 16905571 ↗
• MalfunctionJan 30, 2023Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264694 ↗
• MalfunctionMar 31, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. AT THE END OF THE SURGERY, RADIOGRAPHIC CONFIRMATION WAS PERFORMED AND THE G7 LINER WAS FOUND TO BE PROLAPSED. ALTHOUGH IT IS POSSIBLE THAT THE LINER WAS NOT PLACED CORRECTLY, BUT THE SURGEON SUGGESTED THAT THE LINER WAS DEFECTIVE. THE LINER WAS REMOVED AND REPLACED WITH A BACK-UP OF THE SAME ITEM LINER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966353 ↗