G7® Vivacit-E® 30124006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024520547), received between Mar 23, 2022 and Aug 7, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING HIP SURGERY, THE LINER WOULD NOT SEAT INTO THE CUP. DURING IMPACTION OF THE FINAL LINER, THE SURGEON ALWAYS CHECKS TO SEE THAT IT IS WELL SEATED, AND IT WASN¿T. THE SURGEON RE-IMPACTED THE LINER: HOWEVER, IT STILL DIDN¿T SEAT RIGHT IN THE CUP. ANOTHER LINER WAS USED, AND IT IMPACTED IN THE FIRST TRY. THE LINER WAS VISUALLY INSPECTED, AND IT DID NOT APPEAR BROKEN. NO SCREWS IN THE CUP WERE USED. IT WAS REPORTED THAT THE SURGEON USED THE SAME TECHNIQUE AS USUAL. THERE WAS A ONE-MINUTE DELAY FOR GETTING THE OTHER LINER AND OPENING IT. THERE WAS NO PATIENT IMPACT AND NO SURGICAL COMPLICATIONS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736961 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO SEVERE PAIN AND FAILED IMPLANTS. PATIENT EXPERIENCED PAIN, WEAKNESS, TROCHANTERIC BURSITIS, AND POSSIBLE ILIOPSOAS TENDINITIS. THE SHELL WAS RETAINED AND ALL OTHER IMPLANTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bursitis; Failure of Implant; Inflammation; Muscle Weakness/Atrophy; Pain

  MAUDE report 22183029 ↗
• MalfunctionJan 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LINER WAS BENT WHILE BEING REDUCED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197406 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO REOCCURRING DISLOCATIONS. THE HEAD AND LINER WERE REVISED AS WELL AS THE CUP TO ADD ANTEVERSION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13870431 ↗