Balanced Knee System 163-1509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409009008), received between Mar 19, 2018 and Mar 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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.

• MalfunctionMar 19, 2018Unintended Movement; Unintended Movement

  A PATIENT DIRECTLY CONTACTED OUR COMPANY AND REPORTED THAT HIS INSERT "STICKS OUT" WHEN HE BENDS. WE REFERRED HIM TO HIS SURGEON FOR CONSULTATION. HE INDICATED THAT HE HAD ALREADY CONTACTED HIS SURGEON WHO TOOK X-RAYS AND DETERMINED THAT NOTHING WAS WRONG WITH THE IMPLANTS BUT ASKED HIM TO COME IN FOR MORE TESTING. SUBSEQUENT TO THIS CALL, IT WAS REPORTED THAT THE PATIENT IS SCHEDULED FOR A REVISION SURGERY DUE TO A LOOSE INSERT.

  Patient problems: Arthralgia

  MAUDE report 7351204 ↗

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-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-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-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