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REDAPT 71355345Recalls & reported problems

Smith & Nephew, Inc. · REDAPT 190MM DISTAL REAMER SIZE 14 · Class 2

All models of REDAPT (89)

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 00885556580936), received between Mar 14, 2021 and Mar 14, 2021 — classified as 1 injury.

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

  • Break1

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 14, 2021Break; Break

    IT WAS REPORTED THAT THE END OF REAMER SHAFT BROKE BECAUSE THE DOCTOR WAS USING A "RONGUER" TO TRY AND EXTRACT IT. THE NECK TRIAL WILL NO LONGER ATTACH TO THE REPORTED REAMER. THE EVENT OCCURRED DURING USE, WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11478942 ↗

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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