DJO SURGICAL 202-01-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912109383), received between Feb 7, 2020 and Feb 7, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2020Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: PATIENT PRESENTED 5 YEARS POST OPERATION WITH PAIN DUE TO LAXITY. THE SURGEON SUSPECTED POLY WEAR. HOWEVER INTRAOPERATIVELY IT WAS DISCOVERED THAT ALL COMPONENTS WERE SECURE, FREE FROM ANY DEFECT AND THERE WAS VERY MINIMAL POLY WEAR. SURGEON FELT A THICKER POLY WOULD BENEFIT THE PATIENT. REPLACED 9MM WITH A 15MM.

  Patient problems: Pain

  MAUDE report 9681595 ↗

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