DJO SURGICAL 391-09-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912118972), received between Mar 3, 2016 and Jun 24, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2021Material Too Rigid or Stiff

  REVISION SURGERY - THIS PATIENT UNDERWENT A LYSIS OF ADHESIONS POST-OPERATION FOR A STIFF KNEE. THE POLY WAS EXCHANGED.

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

  MAUDE report 12063423 ↗
• InjuryJul 17, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - WASHED KNEE OUT DUE TO INFECTION AND EXCHANGED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 10289297 ↗
• InjuryDec 18, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO KNEE PAIN.

  Patient problems: Pain

  MAUDE report 9490691 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT HAVING A 20 DEGREE FLEXING PROBLEM IN THE KNEE. THE SURGEON RELEASED THE (PCL) POSTERIOR CRUCIATE LIGAMENT AND SCAR TISSUE. THE SURGEON REMOVED AND REPLACED THE ORIGINAL INSERT.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 8382007 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTED KNEE. THE PATIENT UNDERWENT A WASHOUT AND POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 7134612 ↗
• InjuryJan 19, 2017Unstable

  REVISION SURGERY - DUE TO THE PATIENT'S LEFT KNEE BEING UNSTABLE; THE SURGEON REPLACED THE POLY.

  Patient problems: No Code Available

  MAUDE report 6265246 ↗
• InjuryApr 13, 2016Sticking

  REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING TIGHTNESS IN FLEXION OF KNEE. THE SURGEON REMOVED THE POLY TO REMOVE EXCESS BONE FROM THE POSTERIOR OF THE KNEE.

  Patient problems: No Code Available

  MAUDE report 5575257 ↗
• InjuryMar 3, 2016Unstable

  REVISION SURGERY DUE TO THE PATIENT'S KNEE BECOMING UNSTABLE.

  Patient problems: No Code Available

  MAUDE report 5476884 ↗

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