DJO SURGICAL 391-09-604Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912118842), received between Jan 10, 2019 and Sep 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K020114); 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.

• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO POLY WEAR.

  Patient problems: Joint Laxity

  MAUDE report 20153755 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO WEARING / REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.

  Patient problems: Joint Laxity

  MAUDE report 17578663 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PATIENT'S KNEE WAS INFECTED. THE EXISTING POLYETHYLENE INSERT WAS REMOVED AND THE KNEE WAS THOROUGHLY WASHED OUT. A NEW POLYETHYLENE INSERT WAS PUT IN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 15104544 ↗
• InjuryAug 8, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - INSTABILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8874132 ↗
• InjuryJan 10, 2019Incorrect, Inadequate or Imprecise Result or Readings

  REVISION SURGERY - DUE TO THE PATIENT HAVING KNEE PAIN POST OPERATIVE. THE SURGEON PERFORMED A POLY SWAP.

  Patient problems: Pain

  MAUDE report 8233584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020114. One submission often covers many models, so check the product and lot details in each record.

• Z-2244-2010 · Jun 28, 2010 · Terminated
  3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
• Z-1433-2010 · Mar 19, 2010 · Terminated
  3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee
• Z-1539-2008 · Feb 20, 2008 · Terminated
  3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee
• Z-0332-06 · Nov 3, 2005 · Terminated
  Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
• Z-1011-04 · May 10, 2004 · Terminated
  3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758