G7® Vivacit-E® 30103607Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024519923), received between Aug 28, 2020 and Aug 28, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryAug 28, 2026Device Dislodged or Dislocated

  It was reported the patient underwent a revision approximately 3.5 months post-implantation due to dislocation and malposition of the cup. Attempts have been made, and no further information has been provided.

  Patient problems: Joint Dislocation

  MAUDE report 50495713 ↗
• InjuryMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 21575737 ↗
• InjuryJan 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY THE SAME DAY POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. THERE WAS A HEAD AND LINER EXCHANGE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 21230304 ↗
• InjuryApr 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PMI GROUP THAT A PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A PMI PRODUCT ON AN UNKNOWN DAY FOR AN UNKNOWN REASON. X-RAYS RECEIVED AND REVIEWED, NOTING LOOSENING OF THE ACETABULAR COMPONENT, SUBSIDENCE OF THE FEMORAL COMPONENT, DISLOCATION OF THE FEMORAL HEAD, AND BONE FRACTURE OF THE ACETABULUM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 19116668 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY COMPLETED. SUBSEQUENTLY, PRIOR TO OUTPATIENT DISCHARGE, POST-OPERATIVE ORTHOSTATIC HYPOTENSION AND A RIGHT POSTEROLATERAL HEMATOMA WERE NOTED. THE PATIENT WAS TRANSFERRED FROM THE SURGERY CENTER AND ADMITTED TO A HOSPITAL FACILITY FOR OBSERVATION AND MEDICAL INTERVENTION. SYMPTOMS RESOLVED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE STUDY HAS SINCE BEEN COMPLETED PER PROTOCOL WITH NO FURTHER COMPLICATIONS OR ALLEGATIONS AGAINST THE DEVICE, ALL INITIAL PRODUCT REMAINS IMPLANTED. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 18877590 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION 14 DAYS POSTOP. PATIENT HAD 4 STENTS PLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 17171929 ↗
• InjuryNov 5, 2020Unstable; Unstable

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 MONTHS POST IMPLANTATION DUE TO INSTABILITY. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 10791112 ↗
• MalfunctionAug 28, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN HIP ARTHROPLASTY, THE SURGEON COMPLAINED LINER WOULD NOT SEAT IN CUP. HE IMPACTED THE LINER BUT SAID IT WASN'T CLOSE TO BEING ENGAGED AND THOUGHT THE LINER WAS TOO SMALL FOR THE CUP. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10464812 ↗