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ZUK 00584200302Recalls & reported problems

Smith & Nephew, Inc. · Tibia Base Size 3 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 00885556619766), received between Aug 22, 2023 and Aug 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Failure of Implant1
  • Foreign Body In Patient1
  • Pain1

Recent adverse event reports

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

  • InjuryAug 22, 2023Fracture; Fracture

    IT WAS REPORTED THAT, AFTER AN UNICOMPARTMENTAL KNEE ARTHROPLASTY PERFORMED ON (B)(6) 2020, THE PATIENT WOKE UP AND WHEN ATTEMPTED TO GET OUT OF BED, THE KNEE LOCKED IN A BENT POSITION. AS HE ATTEMPTED TO STRAIGHTEN HIS LEG, HE HEARD A POP AND FELT SOMETHING BREAK. THE PATIENT STARTED TO PRESENT PAIN AND IT WAS CONFIRMED VIA X-RAYS THAT PART OF THE TIBIAL COMPONENT FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO SOLVE THIS ADVERSE EVENT. THE PATIENT IS STILL RECOVERING AND USING CRUTCHES.

    Patient problems: Failure of Implant; Foreign Body In Patient; Pain

    MAUDE report 17597160 ↗

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

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