G7® Vivacit-E® 30103604Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024519893), received between Dec 14, 2020 and Aug 9, 2026 — classified as 11 injuries, 7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2026Difficult to Insert

  It was reported that the liner would not sit in the cup. A bone screw was removed and the liner still did not insert all the way. 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 50189270 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a hip revision. During the procedure the Head and Liner were revised. It was confirmed that no further information could be provided.

  Patient problems: Insufficient Information

  MAUDE report 50174341 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FOLLOW-UP VISIT TWO WEEKS POST-IMPLANTATION, THE PATIENT PRESENTED WITH SLOW WOULD HEALING AND WAS PRESCRIBED AN ANTIBIOTIC. AT THE NEXT FOLLOW-UP, THE ISSUE WAS RESOLVED, AND ALL COMPONENTS REMAIN IMPLANTED WITHOUT COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Impaired Healing

  MAUDE report 24581675 ↗
• InjuryMar 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY ONE-YEAR POST IMPLANTATION DUE TO THE LINER¿S LOCKING MECHANISM FAILING. THE LINER WAS REVISED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 24547669 ↗
• InjuryFeb 26, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 MONTHS LATER DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24455171 ↗
• InjuryJan 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 24051526 ↗
• InjuryNov 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 23463840 ↗
• MalfunctionApr 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864610 ↗
• InjuryFeb 20, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AM INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED TWO (2) MONTHS POST IMPLANTATION DUE TO POLYETHYLENE WEAR. DURING THE REVISION SUBLUXATION OF THE INSERT WAS NOTED, THE SHELL, LINER, AND HEAD WERE REVISED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant; Subluxation

  MAUDE report 21425362 ↗
• MalfunctionNov 19, 2024Difficult to Insert; Difficult to Insert

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726470 ↗
• MalfunctionMar 18, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE PRIMARY LEFT HIP PROCEDURE, THE LINER WOULD NOT ASSEMBLE WITH THE SHELL DURING IMPACTION. ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR HEALTH IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922306 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18259066 ↗
• MalfunctionAug 11, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THERE WAS DEBRIS IN THE PACKAGE. THE STERILIZED BOX WAS OPENED AND THERE WAS DEBRIS THAT APPEARED TO BE A HAIR IN THE TRAY. THE PRODUCT WAS NOT USED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509986 ↗
• InjuryAug 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 17470238 ↗
• MalfunctionMay 1, 2023Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  IT WAS REPORTED THAT THE LINER WOULD NOT SEAT IN THE G7 CUP. THE PROCEDURE WAS COMPLETED USING ANOTHER LINER. THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16848833 ↗
• MalfunctionMar 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13951871 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A STUDY PATIENT UNDERWENT A RIGHT THA. SUBSEQUENTLY, THE PATIENT EXPERIENCED SURGICAL SITE WOUND DEHISCENCE, DRAINAGE, WAS DIAGNOSED WITH DEEP INFECTION, AND HAD PHASE 1 DEVICE REMOVAL, I&D, RESECTION, AND ANTIBIOTIC SPACER PLACEMENT 2 MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fluid Discharge; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 11281985 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED EVENT OF DEEP INFECTION <90 DAYS OCCURRED POST IMPLANTATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS,  AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11003880 ↗