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Arthrex® AR-523-B313Recalls & reported problems

Arthrex, Inc. · PS TIBIAL BEARING, SIZE 3, 13MM, 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 00888867232396), received between Jan 5, 2021 and Jan 5, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1

Patient problems

  • Loss of Range of Motion1

Recent adverse event reports

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

  • InjuryJan 5, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THE A PATIENT HAD UNDERGONE A TKA PROCEDURE (B)(6) 2020. DURING THE JUNE 2020 PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-513-T3, IBALANCE TKA MODULAR TIBIAL TRAY (LOT 10506044), AR-523-B313, IBALANCE TKA BEARING IMPLANT (LOT 5791824), AR-526-6R, IBALANCE FEMORAL IMPLANT (LOT 10259480), AR-524-PSB8, PATELLA IMPLANT DOME (LOT 132581845). ROUGHLY 6 MONTHS POST OP PATIENT BEGAN HAVING ISSUES WITH FULLY EXTENDING THE KNEE. IT WAS REPORTED THERE WAS A POST-OP DISENGAGEMENT OF THE POLY FROM THE TRAY. AT TIME OF REPORT THERE IS NO REVISION SURGERY SCHEDULED AND THE ARTHREX PRODUCTS REMAIN IN THE PATIENT. ADDITIONAL INFORMATION OBTAINED 12/2/20: PATIENT'S REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2020. ADDITIONAL INFORMATION OBTAINED 12/15/20: THE PATIENT'S REVISION PROCEDURE TOOK PLACE AS PLANNED (B)(6) 2020. THE SURGEON WAS ABLE TO MAINTAIN THE EXISTING FEMORAL AND TIBIAL COMPONENTS WHILE JUST REPLACING THE ORIGINAL POLY BEARING, AR-523-B313 (LOT 5791824). AFTER NORMAL EXPOSURE THE SURGEON FOUND THE POLY EXTRUDING ANTERIORLY 1-2 CM, CONSISTENT WITH HIS ASSESSMENT OF PRE-OP X-RAYS. THE POLY WAS REMOVED AND REPLACED WITH THE SAME SIZE COMPONENT, A SIZE

    Patient problems: Loss of Range of Motion

    MAUDE report 11116751 ↗

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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