DJO SURGICAL 392-11-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912120531), received between Dec 21, 2015 and Jul 26, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Unstable” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PAIN AND INSTABILITY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 22622733 ↗
• InjuryAug 29, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 17647425 ↗
• InjuryDec 10, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 12976159 ↗
• InjuryJun 29, 2020Naturally Worn

  REVISION SURGERY - OBESE PATIENT COMPLAINED OF KNEE INSTABILITY. SURGEON THOUGHT IMPLANT MIGHT BE LOOSE. REVISION SURGERY PROVED IMPLANTS STABLE, WELL FIXED BUT POLY INSERT HAD WEAR. POLY EXTRACTED AND REPLACED WITH NEW POLY INSERT.

  Patient problems: No Code Available

  MAUDE report 10206417 ↗
• InjuryJun 7, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY. DUE TO THE PATIENT HAVING A LACK OF RANGE OF MOTION; THE SURGEON REMOVED SCAR TISSUE AND EXCHANGED OUT THE ORIGINAL INSERT.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 6619915 ↗
• InjuryMay 31, 2017Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT'S KNEE HAVING DISLOCATED; THE SURGEON REMOVED AND REPLACED THE ORIGINAL INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 6603334 ↗
• InjuryDec 21, 2015Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO ARTHROFIBROSIS. NO RANGE OF MOTION, LOSS.

  Patient problems: Loss of Range of Motion

  MAUDE report 5315619 ↗

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