G7® Vivacit-E® 30103605Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024519909), received between Jun 23, 2021 and Oct 22, 2025 — classified as 9 injuries, 8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO REPEATED DISLOCATIONS. DURING REVISION OF LINER AND HEAD, THERE WAS A LARGE AMOUNT OF SCAR TISSUE WHICH MAY HAVE CONTRIBUTED TO DISLOCATION. IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation; Scar Tissue

  MAUDE report 23358194 ↗
• InjurySep 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 23061647 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY HIP PROCEDURE. THE PATIENT WAS IMPLANTED WITH A COMPETITOR STEM AND A ZIMMER BIOMET ACETABULAR CUP AND LINER. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING CONSTANT PAIN POST-SURGERY AROUND THE BUTTOCK AREA OF ASSOCIATED HIP REPLACEMENT. THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO PAIN. ALL PRODUCTS WERE REMOVED AND REPLACED. THE PATIENT WAS REIMPLANTED WITH A COMPETITOR STEM AND ZIMMER BIOMET HEAD, CUP AND LINER. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Pain

  MAUDE report 22185649 ↗
• MalfunctionJan 30, 2025Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272787 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN, SWELLING, BURNING SENSATION AND HAS A NICKEL ALLERGY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 21239579 ↗
• MalfunctionOct 15, 2024Manufacturing, 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 20452606 ↗
• InjuryAug 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 3 YEARS LATER DUE TO RECURRENT DISLOCATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 20000192 ↗
• MalfunctionAug 5, 2024Difficult to Insert; Difficult to Insert

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907786 ↗
• MalfunctionMar 25, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967803 ↗
• MalfunctionAug 15, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT WHILE ATTEMPTING TO IMPACT THE LINER INTO THE CUP, THE LINER WOULD NOT SEAT CORRECTLY. THE SURGEON PROCEEDED TO OPEN A SECOND LINER OF THE SAME PRODUCT THAT ASSEMBLED WITHOUT PROBLEMS. THERE ARE NO KNOWN IMPACTS 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 17550063 ↗
• InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON HAD A HARD TIME DISLOCATING THE TRIAL AS THE PATIENT¿S LEG LENGTHS WERE TOO LONG. THE SURGEON WAS UNABLE TO DISLOCATE THE PATIENT FOR AN ANTERIOR APPROACH AND PURPOSELY SHATTERED THE TRIAL HEAD BREAKING THE HEAD INTO PIECES. A BROKEN PIECE REMAINED IN THE PATIENT¿S BODY. THE PATIENT DISLOCATED DUE TO THE BROKEN PIECE AND NEEDED ADDITIONAL SURGERY. THE PATIENT WAS REVISED ONE MONTH POST OPERATION.

  Patient problems: Joint Dislocation

  MAUDE report 17457764 ↗
• MalfunctionJul 31, 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 17426704 ↗
• MalfunctionOct 24, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SCRUB TECH OPENED HIP LINER AND WHEN GOING TO IMPLANT, NOTICED A HAIR INSIDE THE LINER. 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 15657257 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 15 DAYS POST IMPLANTATION DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 14550582 ↗
• InjuryMay 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP CLOSED REDUCTION APPROXIMATELY 21 DAYS POST IMPLANTATION DUE TO DISLOCATION. THE PATIENT WAS SITTING IN A RECLINER, REACHED FORWARD TO PULL UP RIGHT SOCK CAUSING EXTERNAL ROTATION AND DISLOCATED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 14310354 ↗
• InjuryOct 25, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO MECHANICAL LOOSENING. THE HEAD AND LINER WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12691039 ↗
• MalfunctionJun 23, 2021Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050053 ↗