Skip to content

ZUK 00584200202Recalls & reported problems

Smith & Nephew, Inc. · Tibia Base Size 2 Right Medial/Left Lateral · Class 2 · Implant

All models of ZUK (46)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556619742), received between Mar 8, 2021 and Mar 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K033363); they may or may not involve this specific model.

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

  • Defective Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 8, 2021Defective Device; Defective Device

    IT WAS REPORTED THAT TKA DURING SURGERY, THE TIBIAL BASEPLATE SIZE 2 RT MEDIAL/LT LATERAL COMPLETELY BROKE INSIDE THE PATIENT AND DUST WAS COMING OUT. A BACKUP DEVICE WAS NOT AVAILABLE SO IT WAS REQUIRED TO PICKUP A SECOND SET OF IMPLANTS FROM A NEARBY HOSPITAL. A DELAY GREATER THAN 30 MINUTES OCCURRED DUE TO THIS EVENT. NO INJURIES TO PATIENT WERE REPORTED. ADDITIONAL DETAILS ARE NOT AVAILABLE AT THIS MOMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11431784 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033363. One submission often covers many models, so check the product and lot details in each record.

  • Z-1054-2018 · Nov 29, 2017 · Terminated
    ZUK PRC FEM SZB RMED/LLAT ZUK PRC FEM SZC LMED/RLAT ZUK PRC FEM SZC RMED/LLAT NGU PRC FEM SZD LMED/RLAT ZUK PRC FEM SZD RMED/LLAT ZUK PRC FEM SZE LMED/RLAT ZUK PRC FEM SZF RMED/LLA
  • Z-0836-2016 · Jan 11, 2016 · Terminated
    ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful an
  • Z-0076-2014 · Aug 30, 2013 · Terminated
    Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page