Balanced Knee Revision System 561-0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00822409037827), received between Jun 24, 2020 and Jan 23, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT HAD BILATERAL KNEE REVISION SURGERY ON (B)(6) 2024. ON (B)(6) 2025, THE LEFT KNEE WAS REVISED AGAIN. THE CURRENT STATUS OF THE RIGHT KNEE IS UNKNOWN, THE SURGEON NOTED THAT BOTH TAPER LOCKS (FEMORAL AND TIBIAL SLEEVE ASSEMBLIES) OF THE LEFT KNEE WERE LOOSE. THE EXPLANTED IMPLANTS WERE DISCARDED AT THE HOSPITAL. THIS IS REPORT 1 OF 2 FOR THE FEMORAL SIDE OF THIS SURGERY. THE ORIGINAL MODULAR FEMORAL COMPONENT, TAPERED JUNCTION BOX, LOCKING BOLT, AND FEMORAL AUGMENTS WERE LOOSE AT THE TAPER AND THUS EXPLANTED AND DISCARDED. THE SURGEON OPTED TO LEAVE THE ORIGINAL FEMORAL SLEEVE AND STEM IN-SITU AS THEY WERE WELL-FIXED. A NEW TAPERED JUNCTION BOX WITH LOCKING BOLT ALONG WITH A NEW MODULAR FEMORAL COMPONENT WERE ASSEMBLED USING INSTRUMENTATION FROM ANOTHER COMPANY. THE FEMORAL AND TAPERED JUNCTION BOX ASSEMBLY WAS IMPACTED INTO THE ORIGINAL FEMORAL SLEEVE TAPER THAT WAS STILL IN THE FEMUR FROM THE ORIGINAL SURGERY. THE REMOVED FEMORAL COMPONENT WAS SIZE 5L WITH 2 POSTERIOR AUGMENTS. IT WAS REPLACED WITH A NEW SIZE 5L FEMORAL COMPONENT WITH NO AUGMENTS.

  Patient problems: Arthralgia

  MAUDE report 24172922 ↗
• InjuryAug 15, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, A PATIENT RECEIVED A FEMORAL SLEEVE CONSTRUCT AS PART OF THEIR KNEE ARTHROPLASTY. ON (B)(6) 2025, IT WAS REVISED BECAUSE THE JUNCTION BOX HAD FAILED.

  Patient problems: Arthralgia

  MAUDE report 22820931 ↗
• InjuryAug 5, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, A PATIENT RECEIVED A FEMORAL SLEEVE CONSTRUCT AS PART OF THEIR KNEE ARTHROPLASTY. ON (B)(6) 2025, IT WAS REVISED BECAUSE THE JUNCTION BOX HAD BROKEN.

  Patient problems: Arthralgia

  MAUDE report 22717912 ↗
• InjuryNov 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, A PATIENT RECEIVED A TOTAL KNEE REPLACEMENT. ON (B)(6) 2023, THE PATIENT WAS REVISED FOR TIBIAL LOOSENING. IN (B)(6) 2024, THE PATIENT WAS REVISED AGAIN FOR TIBIAL LOOSENING. DURING THE LATEST REVISION, THE FEMORAL COMPONENT WAS DISCOVERED TO BE LOOSE AS WELL AND THE T-NUT FROM THE JUNCTION BOX WAS REMOVED WITH IT. THE TAPERLOCK PORTION OF THE JUNCTION BOX WAS WELL-FIXED TO THE FEMORAL SLEEVE.

  Patient problems: Arthralgia

  MAUDE report 20793176 ↗
• MalfunctionApr 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2024, A FEMORAL KNEE CONSTRUCT WAS X-RAYED AND THE JUNCTION BOX WAS REVEALED TO BE OUT OF POSITION. THIS REPORT IS BEING SUBMITTED BECAUSE AN INTERVENTION COULD RESULT.

  Patient problems: Arthralgia

  MAUDE report 19013338 ↗
• InjuryMar 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2024, A FEMORAL SLEEVE CONSTRUCT WAS REVISED. AFTER EXPOSING THE KNEE, IT WAS NOTED THAT THE JUNCTION BOX SLID ANTERIOR AND POSTERIOR ON THE FEMORAL COMPONENT. THE MORSE TAPER OF THE JUNCTION BOX INTO THE SLEEVE WAS INTACT AND STRONG.

  Patient problems: Arthralgia

  MAUDE report 18831376 ↗
• InjuryJul 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2023, A PATIENT'S KNEE WAS REVISED AFTER FALLING IN (B)(6) 2023. THE PATIENT EXPERIENCED INCREASED SWELLING AND PAIN. THE JUNCTION BOX WAS REPORTED TO BE LOOSE. THE PATIENT'S KNEE WAS A REVISION FROM AN EARLIER (B)(6) 2023 SURGERY WHICH WAS A REVISION FROM A 2013 SURGERY.

  Patient problems: Arthralgia

  MAUDE report 17336931 ↗
• InjuryMar 27, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2021, A TOTAL KNEE REPLACEMENT WAS PERFORMED. IN AN X-RAY DATED (B)(6) 2023, AN ANTERIOR FEMUR FRACTURE WAS DETECTED AND IT APPEARS THAT THE JUNCTION BOX OF THE FEMORAL SLEEVE CONSTRUCT IS LOOSE. A REVISION IS PLANNED BUT HAS NOT YET OCCURRED. THIS REPORT IS BEING SUBMITTED BECAUSE A PROPOSED INTERVENTION WAS MENTIONED EVEN THOUGH IT HAS NOT YET OCCURRED.

  Patient problems: Joint Laxity

  MAUDE report 16620149 ↗
• InjuryJun 24, 2020Unintended Movement; Unintended Movement

  ON (B)(6) 2019, PATIENT HAD RECEIVED A FULL SLEEVE REVISION KNEE CONSTRUCT. ON (B)(6) 2020, PATIENT'S CONSTRUCT WAS REVISED WHEN THE PATIENT HAD PRESENTED WITH PAIN AND A POSSIBLE INFECTED KNEE. UPON OPENING, THE SURGEON FOUND METALLOSIS AND NOTED THAT THE FEMORAL COMPONENT COULD MOVE IN THE ANTERIOR/POSTERIOR DIRECTION WITH RELATION TO THE JUNCTION BOX.

  Patient problems: Pain

  MAUDE report 10189291 ↗