DJO SURGICAL 323-01-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912115094), received between Jan 4, 2016 and Oct 11, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K923277, K970031); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE ORIGINAL TIBIA SUBSIDED MEDIALLY. SURGEON REMOVED THE TIBIA, AND REPLACED IT WITH A STEMMED AND AUGMENTED TIBIA.

  Patient problems: Joint Laxity

  MAUDE report 15581216 ↗
• InjuryJun 2, 2021Collapse; Loose or Intermittent Connection

  REVISION SURGERY - DUE TO LOOSE TIBIA COLLAPSED.

  Patient problems: Insufficient Information

  MAUDE report 11919126 ↗
• InjuryJan 24, 2018Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO THE PATIENT BEING TOO TIGHT IN FLEXION. THE SURGEON REPLACED THE ORIGINAL TIBIA AND INSERT AND ADDED A PATELLA.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7216970 ↗
• InjuryJan 4, 2016Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE PATIENT HAVING ASEPTIC LOOSENING.

  Patient problems: No Code Available

  MAUDE report 5341315 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923277, K970031. One submission often covers many models, so check the product and lot details in each record.

• Z-0349-2012 · Oct 26, 2011 · Terminated
  Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial
• Z-2466-2008 · Aug 4, 2008 · Terminated
  FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of t
• Z-0331-06 · Nov 3, 2005 · Terminated
  Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
• Z-1010-04 · May 10, 2004 · Terminated
  Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
• Z-1069-03 · Apr 24, 2003 · Terminated
  Foundation Knee System, non-porous Femur Size 8, Right