Arthrex® AR-501-UFLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867034266), received between Nov 19, 2018 and Oct 20, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, IT WAS REPORTED BY THROUGH A PATIENT'S LEGAL FILING THAT ON (B)(6) 2017 THE PATIENT UNDERWENT A LEFT KNEE UNI-COMPARTMENTAL KNEE ARTHROPLASTY. DURING THE PROCEDURE THE SURGEON IMPLANTED AN ARTHREX IBALANCE UNI-COMPARTMENTAL KNEE SYSTEM WITH A SIZE 3 FEMORAL COMPONENT, SIZE 4 TIBIAL TRAY, AND AN 8 MM TIBIAL BEARING INSERT INTO THE LEFT KNEE MEDIAL PARAPATELLAR FACETECTOMY. THEREAFTER THE PATIENT WAS HAVING PAIN IN THE LEFT KNEE AND ON (B)(6) 2019 AND MRI OF THE KNEE WAS TAKEN WHICH REVEALED ¿METALLIC ARTIFACT IS PRESENT INVOLVING THE MEDIAL COMPARTMENT OBSCURING AND DISTORTING THE UNDERLYING AND ADJACENT STRUCTURES.¿ ON (B)(6) 2019 THE PATIENT REPORTED A CRUNCHING SENSATION ON THE MEDIAL ASPECT OF THE KNEE. ON (B)(6) 2019 AND AGAIN ON (B)(6) 2020 THE PATIENT COMPLAINED OF ACHES, PAINS AND WEAKNESS IN THE KNEE. ON (B)(6) 2020 THE PATIENT PRESENTED TO ANOTHER SURGEON AND A BONE SCAN WAS ORDERED WHICH REVEALED A LOOSE IMPLANT. THE PATIENT WAS REFERRED TO ANOTHER SURGEON TO DISCUSS REVISION OPTIONS DUE TO LOOSENING OF THE IMPLANT AND ON (B)(6), 2020 THAT SURGEON PERFORMED AN EXPLANTATION AND ANTIBIOTIC SPACER PLACEMENT, LEFT TOTAL KNEE ARTHROPLASTY AND SAUCERIZATION OF F

  Patient problems: Unspecified Infection

  MAUDE report 17980983 ↗
• MalfunctionJan 7, 2021Naturally Worn; Appropriate Device Problem Term/Code Not Available

  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 11134823 ↗
• InjuryNov 19, 2018Loose or Intermittent Connection

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD UNDERGONE A LEFT KNEE MENISECTOMY AND CHONDROPLASTY 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 MANUFACTURER'S

  Patient problems: No Code Available

  MAUDE report 8086820 ↗