Arthrex® AR-501-TBB8Recalls & reported problems
Arthrex, Inc. · iBALANCE UKA TIBIAL BEARING, SIZE 2, 8MM · Class 2 · Implant
Data updated Oct 16, 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 00888867033863), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Naturally Worn” (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.
Most reported problems
Device problems
- Naturally Worn1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2021Naturally Worn
IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE THAT AFTER AN IN INITIAL KNEE SURGERY ON (B)(6) 2014 THE PATIENT DEVELOPED PAIN IN 2018. IT WAS FURTHER REPORTED THAT THERE WAS "CONSECUTIVE WEAR OF THE PE INLAY" AND THE IMPLANT WAS REMOVED DURING A REVISION SURGERY. NO FURTHER INFORMATION WAS PROVIDED. 17-DEC-2020 UPDATE: FURTHER INFORMATION WAS PROVIDED THAT THE INLAY WEAR WAS INITIALLY DIAGNOSED ON THE (B)(6) 2018 AND LATER ON THE (B)(6) 2018 INLAY WEAR WITH CONSECUTIVE WEAR WAS DIAGNOSED. THEREFORE, A REVISION SURGERY WAS PERFORMED ON(B)(6) 2018 AND THE FOLLOWING DEVICES WERE EXPLANTED: IBALANCE UNI TIBIAL TRAY (AR-501-TTLB), IBALANCE UNI TIBIAL BEARING (AR-501-TB8) AND IBALANCE UNI FEMORAL (AR-501-UFLC). THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER¿S PRODUCT.
Patient problems: Pain
MAUDE report 11134762 ↗
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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