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REDAPT 71355438Recalls & reported problems

Smith & Nephew, Inc. · REDAPT 190MM DISTAL REAMER SIZE 17 · 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 00885556584422), received between May 13, 2021 and May 13, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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

  • Material Deformation1

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.

  • InjuryMay 13, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT, DURING A SET UP OR INSPECTION FOR A THR SURGERY, IT WAS NOTICED THAT A REDAPT DISTAL REAMER 190MM SZ 17 WAS CROSS THREADED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11820080 ↗

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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