DJO SURGICAL 324-01-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912115179), received between Jan 3, 2018 and Apr 13, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO PATIENT IS 15+ YEARS POST-OP. PRESENTED WITH TIBIA THAT HAD LOOSENED AND SUBSIDED.

  Patient problems: Insufficient Information

  MAUDE report 11659485 ↗
• InjuryFeb 9, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT PRESENTED WITH PAIN, SURGEON DETERMINED THE TIBIA WAS LOOSE DUE TO POOR BONE HEALTH.

  Patient problems: Pain

  MAUDE report 11304331 ↗
• InjuryJan 3, 2020Break

  REVISION SURGERY - DUE TO FRACTURE ON TIBIAL SIDE.

  Patient problems: Failure of Implant

  MAUDE report 9547552 ↗
• InjuryJul 2, 2019Fracture

  REVISION SURGERY - DUE TO TRAUMA RELATED FRACTURED TIBIA; SURGEON REMOVED EVERYTHING EXCEPT FOR THE PATELLA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8755906 ↗
• InjuryJan 3, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT HAD A TOTAL KNEE ARTHROPLASTY (TKA) PERFORMED IN 2014, SINCE THEN HER LEG HAD BECOME INFECTED. THE SURGEON EXPLANTED THE KNEE COMPONENTS AND WASHED OUT. HE PLACED A TEMPORARY SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 7161044 ↗

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