DJO SURGICAL 391-11-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912119214), received between Mar 24, 2016 and Sep 1, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K091956); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY. REMOVED AND EXCHANGED OUT THE INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10476870 ↗
• InjurySep 8, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE PATIENT HAVING CRUSHED HER TIBIA; THE IMPLANTS BECAME LOOSE. NO INFORMATION WAS GIVEN TO REPRESENTATIVE ON HOW THE PATIENT BECAME INJURED AND THE INFORMATION WAS VERY VAGUE ON WHEN THE FIRST SURGERY OCCURRED. THEY WERE ONLY TOLD 5 PLUS YEARS AGO AT THE SAME HOSPITAL, BUT NO PAST INFORMATION WAS FOUND IN OUR DJO RECORDS.

  Patient problems: Failure of Implant; Injury; No Code Available

  MAUDE report 6853408 ↗
• InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE PATIENT COULD NOT ATTAIN FULL RANGE OF MOTION.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 6616488 ↗
• InjuryMar 24, 2016Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 5523653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091956. One submission often covers many models, so check the product and lot details in each record.

• Z-2659-2017 · May 31, 2017 · Terminated
  3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene
• Z-2658-2017 · May 31, 2017 · Terminated
  3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene
• Z-1213-2013 · Apr 1, 2013 · Terminated
  3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
• Z-2302-2012 · Aug 9, 2012 · Terminated
  3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowin