DJO SURGICAL 335-02-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912115742), received between Mar 27, 2017 and Aug 23, 2023 — classified as 2 injuries.

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

• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 17608680 ↗
• InjuryMar 27, 2017Device Slipped

  REVISION SURGERY - DUE TO PATIENT FALLING ON THEIR KNEE. THEY PRESENTED AT THE SURGEON'S CLINIC WITH KNEE PAIN. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN "LIT UP" AROUND THE TIBIA COMPONENT ACCORDING TO THE SURGEON. THE TIBIAL COMPONENT WAS EVALUATED AND DETERMINED TO BE LOOSE. THE SURGEON REMOVED THE LOOSE TIBIA ALONG WITH THE POLY SPACER AND 4 TIBIAL SCREWS. HE CEMENTED IN A NEW TIBIA BASEPLATE AND PUT IN A NEW POLY LINER.

  Patient problems: Fall; Pain

  MAUDE report 6437508 ↗

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