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NA 75100859Recalls & reported problems

Smith & Nephew, Inc. · TRIAL FEMORAL HEAD 36 XL/+12 · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996121926), received between Jun 16, 2022 and Jun 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Device problems

  • Fracture1

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.

  • MalfunctionJun 16, 2022Fracture; Fracture

    IT WAS REPORTED THAT ONE TRIAL FEMORAL HEADS 36 XL/+12 IS FRACTURED AND WON'T SECURE TO NECK TRIAL. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14711040 ↗

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

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Sources and updates

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