Balance Knee Revision System 563-1512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409004669), received between Aug 27, 2018 and Aug 27, 2018 — 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 27, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2018, THE SURGEON PERFORMED A REVISION OF A RIGHT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2018, THE PATIENT DISLOCATED THE KNEE AND THE SURGEON PERFORMED AN OPEN REDUCTION AND POLY SWAP FROM 12MM TO 14MM. THE SURGEON NOTED THAT THE POSTERIOR LOCKING MECHANISM FOR THE POLY INSERT HAD BEEN DAMAGED.

  Patient problems: Pain

  MAUDE report 7816293 ↗

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-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.
• 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.