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Arthrex® AR-613-49RBRecalls & reported problems

Arthrex, Inc. · iBal TKA Lock Fem Impact, Replace Bumper · Class 1

Data updated Oct 16, 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 00888867284371), received between Sep 19, 2022 and Sep 19, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

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.

  • MalfunctionSep 19, 2022Break

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-49RB REPLACEMENT BUMPERS POLY PORTION OF THE INSTRUMENT SNAPPED OFF. THIS OCCURRED ON (B)(6) 2022 DURING A REVERS. THE CASE WAS COMPLETED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15445950 ↗

Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices

All INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices →

Sources and updates

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