G7® Vivacit-E® 30104007Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024519978), received between Dec 5, 2023 and Sep 29, 2026 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Insert1
Patient problems
- Fluid Discharge1
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934706 ↗InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DURING A CLINICAL STUDY THAT A PATIENT APPROXIMATELY 10 DAYS POST IMPLANTATION A PATIENT DEVELOPED A HEMATOMA AND MILD WOUND DRAINAGE. APPROXIMATELY SEVEN DAYS LATER, AFTER BEING TREATED WITH IV ANTIBIOTICS THE EVENT WAS CONSIDERED RESOLVED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED TO THE SURGICAL SITE OR HIP.
Patient problems: Fluid Discharge; Hematoma; Post Operative Wound Infection; Swelling/ Edema
MAUDE report 18265304 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.