Arthrex® AR-501-TBB0Recalls & reported problems
Arthrex, Inc. · IBAL UKA TIB BEARING,SZ 2,10MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867033825), received between Nov 19, 2018 and Nov 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Loose or Intermittent Connection1
- Patient-Device Incompatibility1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2018Loose or Intermittent Connection; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility
IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD UNDERGONE A LEFT KNEE MENISECTOMY AND "CHRONDROPLASTY" ON (B)(6) 2015. THEREAFTER, ON (B)(6) 2015 THE PATIENT HAD A HEMI-ARTHROPLASTY ON HER LEFT KNEE. THE RECORDS PROVIDED LIST THAT THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE (B)(6) 2015 PROCEDURE: AR-501-TTLB IBALANCE UNI-TIBIAL TRAY (LOT 108761228), AR-501-UFLC IBALANCE UNI-FEMORAL IMPLANT (LOT 1470559) AND AR-501-TBB0 IBALANCE UKA TIBIAL BEARING (LOT 77941142). ON (B)(6) 2015 THE PATIENT UNDERWENT ANOTHER SURGERY CONVERTING THE UNI-KNEE TO A TOTAL KNEE REPLACEMENT. ACCORDING TO THE MEDICAL RECORDS THE PRE-OP DIAGNOSIS, AND X-RAY FINDINGS PRIOR TO THE (B)(6) 2015 PROCEDURE NOTE A LOOSE FEMORAL COMPONENT. HOWEVER, THE OPERATIVE REPORT NOTES THAT THE TIBIAL BASEPLATE WAS LOOSE, NOT THE FEMORAL COMPONENT. DURING THE PROCEDURE THE HEMI-ARTHROPLASTY IMPLANTS WERE REMOVED AND THE FOLLOWING LEFT TKA IBALANCE SYSTEM COMPONENTS WERE IMPLANTED: AR-503-TTTD TIBIAL BASEPLATE (LOT 1297044), AR-517-4L FEMORAL IMPLANT (LOT 1438430), AR-503-A313 TIBIAL BEARING IMPLANT (13MM) (LOT 113601414) AND AR-504-PSA8 PATELLA IMPLANT (LOT 113601322). ANOTHER MANUFACTURE
Patient problems: No Code Available
MAUDE report 8086832 ↗
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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