Balanced Knee System 161-1402Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409007745), received between Sep 23, 2015 and Sep 23, 2015 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K994370); 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 16, 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.

• MalfunctionSep 23, 2015Migration or Expulsion of Device

  DUE TO TIBIAL SUBSIDENCE, A SURGEON REVISED A TOTAL KNEE REPLACEMENT ORIGINALLY IMPLANTED 14 YEARS AGO. DURING KNEE REVISION SURGERY ON (B)(6) 2015, THE SURGEON FOUND THAT THE FEMORAL COMPONENT WAS BEGINNING TO LOOSEN, SO HE REVISED THE FEMORAL COMPONENT AS WELL.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 5104347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994370. One submission often covers many models, so check the product and lot details in each record.

• Z-1904-2020 · May 30, 2019 · Open, Classified
  Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
• Z-1903-2020 · May 30, 2019 · Open, Classified
  Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
• Z-2255-2014 · Jul 11, 2014 · Terminated
  PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
• Z-2254-2014 · Jul 11, 2014 · Terminated
  Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral co
• Z-1610-2014 · Apr 1, 2014 · Terminated
  PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
• Z-1993-2009 · May 29, 2009 · Terminated
  Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300, Ortho Development, Draper, Utah 84020. The Balanced Knee System is in