Arthrex® AR-521-TBC8Recalls & reported problems
Arthrex, Inc. · UKA TIBIAL BEARING, SIZE 3, 8MM, VIT-E · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867233195), received between Jun 7, 2024 and Sep 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Use of Device Problem1
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2024Defective Device; Defective Device
ON 9/6/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-521-TBC8 BALANCE UKA TIBIAL BEARING IMPLANT WOULD NOT ENGAGE INTO THE TIBIA BASEPLATE. THE SURGEON ATTEMPTED TO SNAP THE POLY IN THREE TIMES BEFORE OPENING A NEW ONE. THE AR-521-TBC8 BALANCE UKA TIBIAL BEARING IMPLANT ENGAGED WITH THE TIBIA BASEPLATE ON THE FIRST ATTEMPT WITHOUT ISSUES. THIS WAS DISCOVERED DURING A RIGHT MEDIAL UKA PROCEDURE ON (B)(6)2024.
Patient problems: Insufficient Information
MAUDE report 20300394 ↗MalfunctionJun 7, 2024Use of Device Problem; Use of Device Problem
ON 3/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-521-TBC8 IBALANCE UKA TIBIAL BEARING IMPLANT WOULD NOT INSERT OR ENGAGE IN THE TIBIAL TRAY. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19483905 ↗
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- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
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- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
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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