ZUK 00584209308Recalls & reported problems
Smith & Nephew, Inc. · Vivacit-E Articular Surface Size 3 8mm · Class 2 · Implant
All models of ZUK (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556620939), received between Sep 13, 2019 and Sep 13, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Incomplete or Inadequate Connection2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2019Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT DURING SURGERY, THE POLY WOULD NOT STAY LOCKED IN THE TIBIAL BASE. DELAY OF LESS THAN 30 MINUTES, NO INJURY REPORTED. NO BACKUP DEVICE AVAILABLE, PROCEDURE WAS CONCLUDED WITH A POLY ONE BIGGER SIZE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9029461 ↗MalfunctionSep 13, 2019Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT DURING SURGERY, THE POLY WOULD NOT STAY LOCKED IN THE TIBIAL BASE. DELAY OF LESS THAN 30 MINUTES, NO INJURY REPORTED. NO BACKUP DEVICE AVAILABLE, PROCEDURE WAS CONCLUDED WITH A POLY ONE BIGGER SIZE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9028304 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
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- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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