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Arthrex® AR-523-B414Recalls & reported problems

Arthrex, Inc. · PS TIBIAL BEARING, SIZE 4, 14MM, VIT E · Class 2 · Implant

Data updated Oct 18, 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 00888867232501), received between Sep 6, 2022 and Sep 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionSep 6, 2022Detachment of Device or Device Component

    ON (B)(6) 2022 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA PHONE THAT AN AR-523-B414 TIBIAL BEARING POPPED OUT OF THE TIBIAL TRAY. THIS OCCURRED AFTER A CASE. REVISION SURGERY ON (B)(6) 2022, REPLACED WITH AN AR-513-BE16, BATCH NUMBER 113601819.

    Patient problems: Insufficient Information

    MAUDE report 15361901 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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