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Arthrex® AR-523-R511Recalls & reported problems

Arthrex, Inc. · CR TIBIAL BEARING, SIZE 5, 11MM, 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867244443), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fitting Problem” (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

  • Fitting Problem1
  • Unstable1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryJan 8, 2019Unstable; Fitting Problem

    IT WAS REPORTED THAT A REVISION LEFT TOTAL KNEE PROCEDURE TOOK PLACE ON (B)(6) 2018 DUE TO INSTABILITY. ORIGINAL SURGERY WAS PERFORMED BY A SURGEON ON (B)(6) 2017. THE ORIGINAL TIBIA COMPONENT IMPLANTED ON (B)(6) 2017 WAS EXPLANTED DURING THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2018. THE REVISION PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE EXPLANTED DEVICE APPEARED INTACT, AND INTEGRITY UNAFFECTED. TIBIA POLY EXCHANGE, CR+ 5//16, PATIENT PRESENTED WITH APPROPRIATE SPACING AND STABILITY. SURGEON ATTEMPTED A 5//18 TIBIA POLY, BUT IT DID NOT FIT. DISTAL TIBIA TENDON INSERTION WAS REPAIRED USING A 4.75 DOUBLE LOADED SWIVELOCK AND THEN SURGEON PROCEEDED WITH CLOSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED (B)(4) 2018: THE REP CONFIRMED THAT THE CORRECT DATE OF THE ORIGINAL PROCEDURE WAS (B)(6) 2017. THE REP STATED THAT AR-523-R511 (LOT: 5791630) WAS EXPLANTED DURING THE REVISION SURGERY, AND AR-503-A516 (LOT 113601428) WAS IMPLANTED DURING THE REVISION SURGERY. THE SURGEON STATED THAT THE REVISION SURGERY WAS NOT DUE TO AN ARTHREX DEVICE. THE REVISION TOOK PLACE DUE TO LIGAMENT ISSUES, NOT ARTHREX IMPLANTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8226746 ↗

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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