Balance Knee Revision System 561-5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409004140), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K060569); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2023, AN X-RAY SHOWED A DISLODGED COMPONENT FROM THE ORIGINAL SURGERY AND AN ANTERIOR FEMORAL FRACTURE WHICH LIKELY MEANS THE JUNCTION BOX AND STEM HAVE MIGRATED. X-RAYS FROM ORIGINAL SURGERY HAVE NOT BEEN PROVIDED. NO REVISION SURGERY HAS BEEN REPORTED. THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION BECAUSE A PROPOSED INTERVENTION MAY BE PERFORMED EVEN THOUGH IT HAS NOT YET OCCURRED.

  Patient problems: Arthralgia

  MAUDE report 17561432 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060569. One submission often covers many models, so check the product and lot details in each record.

• Z-2257-2014 · Jul 11, 2014 · Terminated
  Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for artic
• Z-1740-2011 · Jan 7, 2011 · Terminated
  UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision.
• Z-1741-2011 · Jan 7, 2011 · Terminated
  CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision.
• Z-1742-2011 · Jan 7, 2011 · Terminated
  UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 The tibial insert is a device that fits into the tibial tray during knee revision.