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R3 71366077Recalls & reported problems

Smith & Nephew, Inc. · R3 TRIAL LINER TRAY 0 DEGREE AND 20 DEGREE · Class 1

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 03596010580030), received between Jan 20, 2020 and Jan 20, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 20, 2020Break; Break

    IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY BLACK IMPACTOR HEAD BROKE. THE DEVICE BROKE INSIDE THE PATIENT AND ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS FINISHED WITH A BACKUP DEVICE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9606887 ↗

Other TRAY, SURGICAL, INSTRUMENT devices

All TRAY, SURGICAL, INSTRUMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.