DJO SURGICAL 324-01-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912115186), received between Oct 14, 2016 and Dec 12, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PAIN DUE TO TIBIAL LOOSENING.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15959153 ↗
• InjuryOct 23, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - PATIENT HAD A BAD FALL AND LOOSENED THE TIBIA. SURGEON FELT IT NEEDED TO A STEM TO SECURE IT.

  Patient problems: Fall

  MAUDE report 9226113 ↗
• InjuryMay 25, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE PATIENT HAVING KNEE PAIN DUE TO LOOSENING OF THE TIBIA.

  Patient problems: Pain

  MAUDE report 7546439 ↗
• InjuryOct 14, 2016Break

  REVISION SURGERY: DUE TO THE PATIENT FALLING AND BREAKING THEIR TIBIA; NOT IMPLANT RELATED.

  Patient problems: No Code Available

  MAUDE report 6031800 ↗

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