G7® Vivacit-E® 30103203Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024519831), received between Apr 30, 2021 and Sep 28, 2026 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported in a clinical study that the patient received a cortisone injection approximately one-year post-implantation due to iliopsoas tendinitis, bursitis, and pain. The event was marked as ongoing but improving with no further complications reported at this time. No additional information available for the reported event.

  Patient problems: Bursitis; Pain; Tendinopathy

  MAUDE report 50914783 ↗
• MalfunctionJun 14, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A HAIR IN THE POLY BOX. 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 25497611 ↗
• MalfunctionFeb 3, 2026Difficult to Insert; Separation Failure

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE LINER WOULD NOT SEAT NEATLY. THE LINER BECAME SLIGHTLY DETACHED FROM THE REAR OUTER SIDE OF THE CUP. THE SURGEON TRIED TO REMOVE IT SEVERAL TIMES WITH AN ELEVATOR BUT COULD NOT. THE SURGEON DECIDED TO KEEP THE LINER IMPLANTED AS IS. 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 24249462 ↗
• MalfunctionJul 8, 2025Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438297 ↗
• MalfunctionMay 15, 2025Difficult to Insert; Difficult to Insert

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025374 ↗
• MalfunctionDec 11, 2024Difficult to Insert; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905220 ↗
• InjuryMar 26, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT A PATIENT UNDERWENT A LEFT HIP PROCEDURE. APPROXIMATELY, NINE DAYS POST IMPLANTATION FOR PAIN AND INSTABILITY. ALL OF THE ITEMS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE. AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Osteopenia/ Osteoporosis; Pain

  MAUDE report 18977314 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL, THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, POST-OPERATIVE IMAGING DEMONSTRATED A SIZE MISMATCH BETWEEN THE FEMORAL HEAD AND ACETABULAR LINER IMPLANTED. AS A RESULT, REVISION SURGERY OCCURRED WHERE THE SIZE 36MM HEAD WAS EXCHANGED FOR A SIZE 32MM HEAD. THE PATIENT REPORTED BILATERAL HIP PAIN WITH LEFT HIP BEING GREATER THAN THE RIGHT AND NOT BEING ABLE TO WALK UP OR DOWN STAIRS. PATIENT WAS PRESCRIBED AQUA THERAPY BUT HAS REPORTED SHE HAS YET TO START DUE TO FINANCIAL REASONS. THE PATIENT UNDERWENT A PROCEDURE FOR IMPLANTATION OF A LUMBAR SPINAL CORD STIMULATOR. DURING A FOLLOW-UP APPOINTMENT, THE PATIENT REPORTS 100% PAIN RELIEF. NO FURTHER ALLEGATIONS HAVE BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Unequal Limb Length

  MAUDE report 18907214 ↗
• InjuryMar 4, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT UPON THE LINER DID NOT FIT WELL INTO THE CUP. THE SURGEON REPEATEDLY TAPPED THE CUP, WHICH LOOSENED AND CAUSED A FRACTURE OF THE ACETABULUM. THERE WAS AN APPROXIMATE 15-MINUTE DELAY DUE TO DIFFICULTY WITH THE PROCEDURE AND PRODUCT REPLACEMENT. IT WAS REPORTED THAT SURGICAL TECHNIQUE WAS UTILIZED. THIS PRODUCT WAS NOT USED. AFTER SURGERY, THIS LINER WAS PLACED IN THE CUP FOR CONFIRMATION AND COULD BE INSERTED. THERE WAS NO REPORTED SERIOUS INJURY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18825082 ↗
• InjuryOct 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Subluxation

  MAUDE report 17904612 ↗
• MalfunctionApr 12, 2023Difficult 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 16727008 ↗
• MalfunctionAug 10, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE LINER WOULDN'T GO IN THE CUP. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199338 ↗
• InjuryFeb 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY THE PATIENT DISLOCATED AND UNDERWENT A CLOSED REDUCTION APPROXIMATELY 20 DAYS POST IMPLANTATION. IMPLANTS REMAINED INTACT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13444043 ↗
• InjuryApr 30, 2021Difficult to Insert; Difficult to Insert

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

  Patient problems: Bone Fracture(s)

  MAUDE report 11752186 ↗