Arthrex® AR-521-TBB8Recalls & reported problems
Arthrex, Inc. · UKA TIBIAL BEARING, SIZE 2, 8MM, VIT-E · Class 2 · Implant
Data updated Oct 16, 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 00888867231368), received between Jul 5, 2024 and Sep 4, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device1
- Fitting Problem1
- Positioning Failure1
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 4, 2025Device Damaged by Another Device; Device Damaged by Another Device
ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-07011239 THAT AN AR-521-TBB8 IBALANCE® UKA TIBIAL BEARING IMPLANTS INITIAL INSERT HAD TO BE REMOVED AND A LARGER ONE PLACED AFTER CHANGING THE TIBIA. THE IMPLANT WAS VERIFIED AND THE REPORTED DAMAGE WAS CONFIRMED. THIS OCCURRED DURING USE.
Patient problems: Insufficient Information
MAUDE report 22962088 ↗MalfunctionJul 5, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem
ON 06/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-521-TBB8 IBALANCE® UKA TIBIAL BEARING IMPLANT WAS NOT LOCKING INTO THE TIBIAL TRAY. THIS OCCURRED DURING A PARTIAL KNEE REPLACEMENT ON (B)(6) 2024 THAT WAS COMPLETED USING ANOTHER AR-521-TBB8 IBALANCE® UKA TIBIAL BEARING IMPLANT.
Patient problems: Insufficient Information
MAUDE report 19683702 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- 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
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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