G7® Vivacit-E® 30103206Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024519862), received between Sep 18, 2020 and Aug 9, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE LINER WOULD NOT SEAT INTO THE CUP. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189431 ↗
• MalfunctionSep 18, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED INCOMING INSPECTION TEAM MEMBER FOUND THERE IS A HOLE ON THE OUTER PACKAGE AND IT WAS PENETRATED INTO THE STERILE PACKAGE. NO ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 10553725 ↗