DJO SURGICAL 202-01-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912109437), received between Aug 28, 2018 and Mar 29, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K923277); 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.

• InjuryMar 29, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH SEVERE INFECTION. THE SURGEON REMOVED AND REPLACED THE FEMORAL COMPONENT AND THE TIBIAL INSERT IN ORDER TO PERFORM AN IRRIGATION AND DRAINAGE (I&D).

  Patient problems: Unspecified Infection

  MAUDE report 8464659 ↗
• InjuryAug 28, 2018Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - DUE TO THE PATIENT FALLING AND BEGINNING TO LOOSEN.

  Patient problems: Fall

  MAUDE report 7824460 ↗

Recalls under the same FDA submission

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

• 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