Balanced Knee System 162-1400ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00822409010158), received between Jun 13, 2019 and Jun 13, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, THE SURGEON HAD DIFFICULTY ASSEMBLING THE INSERT TO THE TIBIAL TRAY AND USED A MALLET. THE INITIAL REPORTER INDICATED THERE WERE 3 EVENTS RELATED TO DIFFICULTY IN ASSEMBLING. THIS IS REPORT 3 OF 3.

  Patient problems: Pain

  MAUDE report 8697768 ↗
• MalfunctionJun 13, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, THE SURGEON HAD DIFFICULTY ASSEMBLING THE INSERT TO THE TIBIAL TRAY. THE INITIAL REPORTER INDICATED THERE WERE 3 EVENTS RELATED TO DIFFICULTY IN ASSEMBLING. THIS IS REPORT 2 OF 3.

  Patient problems: Pain

  MAUDE report 8697691 ↗
• MalfunctionJun 13, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, THE SURGEON HAD DIFFICULTY ASSEMBLING THE INSERT TO THE TIBIAL TRAY AND USED A MALLET. THE INITIAL REPORTER INDICATED THERE WERE 3 EVENTS RELATED TO DIFFICULTY IN ASSEMBLING. THIS IS REPORT 1 OF 3.

  Patient problems: Pain

  MAUDE report 8697653 ↗

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