Arthrex® AR-521-TBA8Recalls & reported problems
Arthrex, Inc. · UKA TIBIAL BEARING, SIZE 1, 8MM, VIT-E · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867231283), received between Dec 16, 2019 and Jul 10, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (3 reports).
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
- Fitting Problem3
- Positioning Failure2
- Failure to Advance1
- Naturally Worn1
- Unstable1
Patient problems
- Insufficient Information4
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Fitting Problem; Fitting Problem
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-521-TBA8 IBALANCE UKA TIBIAL BEARING IMPLANTS FAILED TO SNAP INTO THE TRAY. MULTIPLE TECHNIQUES WERE ATTEMPTED, AND THE TRAY WAS CONFIRMED TO BE FREE OF DEBRIS; HOWEVER, NEITHER 8MM TIBIAL BEARINGS COULD BE SECURED INTO THE LOCKING TABS. THE COMPONENT REMAINED PROUD EITHER AT THE CENTRAL PORTION OR ON THE MEDIAL SIDE OF THE TRAY. THIS ISSUE WAS IDENTIFIED DURING A RIGHT MEDIAL UKA PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 6/25/2025.
Patient problems: Insufficient Information
MAUDE report 22469173 ↗MalfunctionApr 25, 2024Failure to Advance; Failure to Advance
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-521-TBA8 UKA TIBIAL BEARING IMPLANT WOULD NOT GO IN. SURGEON OPENED A NEW PRODUCT AND CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.
Patient problems: Insufficient Information
MAUDE report 19179543 ↗MalfunctionMar 28, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem
ON 03/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT ((2) AR-521-TBA8 IBALANCE® UKA TIBIAL BEARING IMPLANTS WERE NOT LOCKING INTO THE AR-511-T1L IBALANCE® UKA TIBIAL TRAY. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 18997644 ↗MalfunctionMar 28, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem
ON 03/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT ((2) AR-521-TBA8 IBALANCE® UKA TIBIAL BEARING IMPLANTS WERE NOT LOCKING INTO THE AR-511-T1L IBALANCE® UKA TIBIAL TRAY. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 18994410 ↗InjuryDec 16, 2019Unstable; Naturally Worn
THE PATIENT HAD ORIGINAL SURGERY FOR A UNI KNEE REPLACEMENT ON (B)(6) 2018. SHE REPORTED PAIN AND INSTABILITY; XRAYS SHOWED THAT THE POLY HAD WORN DOWN. ARTHREX PARTS AR-521-TBA8, AR-501-UFLD AND AR-501-TTLA WERE REMOVED. A TOTAL KNEE REVISION WAS DONE ON (B)(6) 2019 WITH A COMPETITOR'S DEVICE. PATIENT FEMALE, 60S.
Patient problems: Pain
MAUDE report 9473603 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
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- 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
- 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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