Arthrex® AR-521-TBD0Recalls & reported problems
Arthrex, Inc. · UKA TIBIAL BEARING, SIZE 4, 10MM, 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 00888867233218), received between Jul 15, 2025 and Jul 15, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
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.
MalfunctionJul 15, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-521-TBD0 IBALANCE UKA TIBIAL BEARING IMPLANT MALFUNCTIONED DURING INSERTION AND FAILED TO LOCK INTO THE TIBIAL TRAY. THIS WAS DISCOVERED DURING A UKA PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/27/2025: DURING THE PROCEDURE, THE AR-521-TBD0 IBALANCE UKA TIBIAL BEARING IMPLANT PARTIALLY ENGAGED. MILD RESISTANCE WAS ENCOUNTERED DURING INSERTION. DURING THE ATTEMPTED INSERTION, THE LOCKING TABS OF THE IMPLANT BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. TO COMPLETE THE CASE, A SECOND AR-521-TBD0 WAS OPENED AND SUCCESSFULLY USED. THE SURGERY WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. THERE HAVE BEEN NO REPORTS OF PATIENT HARM OR ADVERSE EFFECTS ON OR AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22507727 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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