G7® Vivacit-E® 30113607Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024520219), received between Dec 9, 2021 and Feb 18, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (2 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert2
- Device Dislodged or Dislocated1
- Naturally Worn1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Ambulation or Postural Difficulties1
- Failure of Implant1
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation; Pain
MAUDE report 21397346 ↗MalfunctionOct 24, 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 17995277 ↗MalfunctionAug 15, 2022Positioning Failure; Positioning Failure
IT WAS REPORTED LINER WOULD NOT SEAT CUP. THE CUP WAS DRIED; SCREWS WERE CHECKED TO ENSURE THEY WERE DOWN THE ENTIRE WAY. EVENTUALLY A NEW 10-DEGREE LINER WAS OFFERED AND IT IMMEDIATELY SEATED CORRECTLY. 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 15225545 ↗MalfunctionDec 9, 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 12969164 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.