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NA 71320428Recalls & reported problems

Smith & Nephew, Inc. · ZIRCONIA 12/14 TAPER FEMORAL HEAD 28MM + 4 · Class 2 · Implant

Data updated Oct 16, 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 03596010196255), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Metal Related Pathology1

Recent adverse event reports

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

  • InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A (B)(6) YEARS OLD THR, A REVISION SURGERY WAS PERFORMED DUE TO EXTENSIVE POLY WEAR. SURGEON PERFORMED A STANDARD POSTERIOR APPROACH AS PER SURGICAL TECHNIQUE ALSO A DEBRIMENT OF THE AFFECTED TISSUE. METALOSIS WAS FOUND. THE ZIRC 12/14 FEM HD 28 + 4 AND REF LNR 28ID 20 DEG SZ F WERE EXPLANTED AND EXCHANGE FOR NEW POLY AND HEAD. PATIENT OUTCOME IS UNKNOWN.

    Patient problems: Metal Related Pathology

    MAUDE report 11587202 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices →

Sources and updates

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