DJO SURGICAL 392-11-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912120470), received between Oct 5, 2017 and Aug 27, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Adverse 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 22909906 ↗
• InjuryMay 6, 2025Adverse 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 21973481 ↗
• InjurySep 14, 2021Naturally Worn

  REVISION SURGERY - DUE TO POLY WEAR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12469417 ↗
• InjuryJan 31, 2018Naturally Worn

  REVISION SURGERY - DUE TO THE PATIENT SHOWING POLY WEAR RADIOGRAPHICALLY. A POLY EXCHANGE SURGERY WAS REQUIRED TO PREVENT FURTHER DETERIORATION OF THE IMPLANT.

  Patient problems: No Code Available

  MAUDE report 7231398 ↗
• InjuryOct 5, 2017Naturally Worn

  REVISION SURGERY - DUE TO THE PATIENT HAVING COMPLAINED OF PAIN FROM THEIR TOTAL KNEE DONE SEVERAL YEARS AGO. THE SURGEON PERFORMED SURGERY AND HAD TO REMOVE ALL COMPONENTS DUE TO EXTREME POLY INSERT WEAR AND OSTEOLYSIS; THE POLY INSERT WAS SIGNIFICANTLY COMPRESSED.

  Patient problems: Osteolysis; Pain

  MAUDE report 6919158 ↗

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