Arthrex® AR-521-TBE8Recalls & reported problems
Arthrex, Inc. · UKA TIBIAL BEARING, SIZE 5, 8MM, VIT-E · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867233317), received between Mar 28, 2024 and Jun 19, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (2 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 Problem2
- Positioning Failure2
- Device Dislodged or Dislocated1
- Positioning Problem1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2024Positioning Problem; Positioning Problem
ON 12/13/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-521-TBE8 IBALANCE UKA TIBIAL BEARING IMPLANT TIBIAL INSERT FAILED TO SEAT PROPERLY WITH NO SOFT TISSUE, BONE OR CEMENT INTERFERING WITH THE LOCKING MECHANISM. THIS WAS DISCOVERED DURING A UKA PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW AR-521-TBE8.
Patient problems: Insufficient Information
MAUDE report 19569571 ↗MalfunctionJun 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED DURING A KNEE PROCEDURE, THE AR-521-TBE8 (LOT: 579202821)TIBIAL BEARING IMPLANT WOULD NOT SEAT INTO THE TIBIAL TRAY. THE CASE WAS COMPLETED USING A 2ND AR-521-TBE8 (579200004)TIBIAL BEARING IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19444683 ↗MalfunctionMar 28, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT ((2) AR-521-TBE8 IBALANCE® UKA TIBIAL BEARING IMPLANTS WERE NOT LOCKING INTO THE AR-511-T5R 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 18994661 ↗MalfunctionMar 28, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT ((2) AR-521-TBE8 IBALANCE® UKA TIBIAL BEARING IMPLANTS WERE NOT LOCKING INTO THE AR-511-T5R 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 18991064 ↗
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
- 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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