DJO SURGICAL 392-11-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912120449), received between Dec 23, 2015 and Sep 26, 2018 — classified as 6 injuries.

The most frequently reported specific device problem is “Unstable” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO A LOOSE COMPONENT. THE SURGEON REMOVED THE POLY.

  Patient problems: No Code Available

  MAUDE report 7910797 ↗
• InjuryJun 7, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO A POLY SWAP BEING DONE.

  Patient problems: No Code Available

  MAUDE report 6619490 ↗
• InjuryMay 25, 2017Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 6591432 ↗
• InjuryMar 27, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT PRESENTING WITH IDIOPATHIC PATELLO-FEMORAL PAIN. THE SURGEON RE-OPERATED ON THE RIGHT KNEE THROUGH THE TRADITIONAL MEDIAL PARA-PATELLAR INCISION, REMOVED SCAR TISSUE SURROUNDING THE PATELLA IMPLANT, RELEASED THE PATELLA LATERALLY AND REPLACED THE POLYETHYLENE TIBIAL BEARING FROM A (392-11-606) SIZE 6X11MM TO A (392-13-706) SIZE 6X13MM IMPLANT. HE THEN CLOSED IN A TRADITIONAL MANNER USING SUTURES AND STAPLES.

  Patient problems: Pain; Scar Tissue

  MAUDE report 6437573 ↗
• InjuryMar 16, 2017Unstable

  REVISION SURGERY - THE PATIENT HAD RIGHT TOTAL KNEE ARTHROPLASTY (TKA) IN 2006. RECENTLY THEY DEVELOPED SOME PAIN AND JOINT INSTABILITY AND THE SURGEON PERFORMED A SYNOVECTOMY WITH A POLY EXCHANGE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6410966 ↗
• InjuryDec 23, 2015Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE SURGEON RE-OPENED DUE TO SYNOVITIS AND DECIDED TO REPLACE THE POLY SINCE HE WAS ALREADY OPENED UP.

  Patient problems: Synovitis

  MAUDE report 5323969 ↗

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