DJO SURGICAL 323-01-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912115087), received between Sep 3, 2015 and Sep 6, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2018Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT FALLING AFTER HAVING PRIMARY KNEE REPLACEMENT SURGERY AND DISPLACED THE TIBIAL COMPONENT. THE SURGEON AND THE PATIENT DECIDED TO REMOVE THE DISPLACED TIBIAL COMPONENT AND REPLACE IT WITH A NEW ONE.

  Patient problems: Fall

  MAUDE report 7853314 ↗
• InjurySep 3, 2015Loose or Intermittent Connection; Unstable

  REVISION SURGERY DUE TO ASEPTIC LOOSING OF THE BASEPLATE. THE PATIENT COMPLAINED OF PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 5054410 ↗

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