DJO SURGICAL 392-09-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912120173), received between Dec 23, 2015 and Dec 10, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE CAPSULE NEEDED TO BE CLEANED OUT. SURGEON REPLACED POLY AS A PRECAUTIONARY MEASURE.

  Patient problems: Unspecified Infection

  MAUDE report 23774413 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN.

  Patient problems: Implant Pain

  MAUDE report 21175484 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT COMPLAINT OF PAIN.

  Patient problems: Implant Pain

  MAUDE report 20035828 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16424136 ↗
• InjurySep 13, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO POLY SWAP AND PATIENT UNSTABLE.

  Patient problems: Insufficient Information

  MAUDE report 12464999 ↗
• InjuryFeb 13, 2019Naturally Worn

  REVISION SURGERY - UNUSUALLY HIGH POLYETHYLENE WEAR AFTER IMPLANTATION IN 2010.

  Patient problems: No Code Available

  MAUDE report 8336667 ↗
• InjuryMay 30, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT'S KNEE BEING UNSTABLE. THE SURGEON REMOVED AND REPLACED THE INSERT.

  Patient problems: No Information

  MAUDE report 6599791 ↗
• InjuryMar 16, 2017Naturally Worn

  REVISION SURGERY - THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY (TKA) PERFORMED IN 2012, AND HAD DEVELOPED SIGNIFICANT MEDIAL WEAR ON THE POLY INSERT. THE SURGEON PERFORMED A POLY EXCHANGE AND SYNOVECTOMY TO CORRECT MAL-ALIGNMENT.

  Patient problems: Failure of Implant

  MAUDE report 6410911 ↗
• InjuryFeb 7, 2017Naturally Worn

  REVISION SURGERY - THE POLY INSERT HAD BECOME WORN DUE TO HIGH LEVEL OF ACTIVITY FROM THE PATIENT AND IT NEEDED TO BE REPLACED. NO COMPONENT FAILURE PRESENT.

  Patient problems: No Code Available

  MAUDE report 6307521 ↗
• InjuryDec 23, 2015Inadequacy of Device Shape and/or Size

  Patient problems: Pain

  MAUDE report 5324696 ↗

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