G7® Vivacit-E® 30104006Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024519961), received between Jan 16, 2024 and Apr 24, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Manufacturing, Packaging or Shipping Problem2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Joint Dislocation2
- Medical device site infection1
- Necrosis1
- Pain1
- Scar Tissue1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. THE PATIENT WAS REVISED APPROXIMATELY TWO WEEKS LATER DUE TO MALPOSITION, INCORRECT SIZING, DISLOCATION AND INSTABILITY. IT WAS REPORTED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 24982043 ↗MalfunctionNov 3, 2025Difficult to Insert; Difficult to Insert
NO ADDITIONAL EVENT INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23456086 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY ONE AND A HALF YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INFECTION, PAIN, INFLAMMATION, AND HEAD AND TRUNNION DISASSOCIATION DEMONSTRATED ON X-RAYS. DURING THE REVISION THE HEAD WAS CONFIRMED FRACTURED, THERE WAS SIGNIFICANT SCAR TISSUE, AND NECROTIC TISSUE WAS DEBRIDED FROM THE CUP. ALL COMPONENTS REVISED AND A CEMENT SPACER IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Medical device site infection; Necrosis; Pain; Scar Tissue
MAUDE report 22882931 ↗InjuryAug 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. IT WAS REPORTED NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation
MAUDE report 22826699 ↗MalfunctionSep 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20256235 ↗MalfunctionJan 16, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18521354 ↗
Other Hip, semi-constrained, cemented, metal/polymer + additive, cemented devices
- G7® Acetabular System 010000664Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented20 reports
- G7® Acetabular System 110010245Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7 ACETABULAR SCREW 010000999Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented19 reports
- G7 Acetabular Liner 010000850Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented15 reports
- G7® Acetabular System 110010242Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7® Acetabular System 010000661Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented13 reports
- G7 Acetabular Liner 010000937Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented1 death12 reports
- G7 OSSEOTI ACETABULAR SHELL 110010243Biomet Orthopedics, LLC · Hip, semi-constrained, cemented, metal/polymer + additive, cemented10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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