Continuum® Trilogy® Allofit® Vivacit-E® 00-8851-013-36Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Continuum Trilogy Allofit Vivacit-E (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00889024155077), received between Dec 12, 2019 and Dec 20, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Consequences Or Impact To Patient1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL THA. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION. THE HEAD AND LINER COMPONENTS WERE REMOVED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT.
Patient problems: Unspecified Infection
MAUDE report 9503016 ↗MalfunctionDec 12, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9457222 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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