DJO SURGICAL 392-09-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912120289), received between Jan 14, 2016 and Feb 4, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Unstable” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Unstable

  REVISION SURGERY - DUE TO STIFF KNEE WITH MINIMAL RANGE OF MOTION.

  Patient problems: Loss of Range of Motion

  MAUDE report 24264692 ↗
• InjuryOct 30, 2025Unstable; Unstable

  REVISION SURGERY - DUE TO LOOSENING.

  Patient problems: Joint Laxity

  MAUDE report 23432948 ↗
• InjuryJan 12, 2024Adverse 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 18509298 ↗
• InjuryAug 29, 2023Adverse 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 17647423 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 17083795 ↗
• InjuryAug 5, 2021Unstable

  REVISION SURGERY - DUE TO INSTABILITY. 9MM LINER WAS REMOVED AND REPLACED WITH A 6/11 INSERT.

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

  MAUDE report 12281655 ↗
• InjuryJan 13, 2021Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY - POLY SWAP FOR INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 11163284 ↗
• InjuryNov 5, 2020Unstable

  REVISION SURGERY - DUE TO PATIENT EXPERIENCING PAIN IN KNEE WHILE DRIVING, AS WELL AS, INSTABILITY. REMOVED AND EXCHANGED OUT THE INSERT.

  Patient problems: Pain

  MAUDE report 10793960 ↗
• InjuryApr 2, 2020Unstable

  REVISION SURGERY - KNEE WAS UNSTABLE. REMOVED AND EXCHANGED OUT THE INSERT.

  Patient problems: Failure of Implant

  MAUDE report 9917238 ↗
• InjurySep 18, 2019Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9085010 ↗
• InjuryJul 26, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE KNEE WAS INFECTED, SO THEY REMOVED THE POLY, WASHED IT OUT AND PUT IN A NEW POLY THAT WAS THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 8831946 ↗
• InjuryJan 26, 2018Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO A KNEE DISLOCATION.

  Patient problems: No Code Available

  MAUDE report 7222472 ↗
• InjuryAug 8, 2017Device Operates Differently Than Expected

  REVISION SURGERY - THE PATIENT HAS HAD MANY KNEE SURGERIES ON HIS RIGHT KNEE AND AS A RESULT HAD A SIGNIFICANT AMOUNT OF SCAR TISSUE THAT CONTINUED TO MAKE HIS KNEE HURT AND HE ALSO HAD LIMITED MOTION ESPECIALLY AROUND HIS PATELLA. IN SURGERY, THEY FOUND A LOT OF SCAR TISSUE AND OSSIFICATION LATERAL TO THE PATELLA. THE SURGEON RELEASED THIS SCAR TISSUE AND OSSIFICATION TO REGAIN MOBILITY IN THE PATELLAR REGION THEN CHANGED OUT PATELLA, PATIENT KNEE SHOWED INCREASED FLEXION AND MOBILITY AFTER HIS RELEASE IN OPERATING ROOM (OR).

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Scar Tissue

  MAUDE report 6775325 ↗
• InjuryMar 31, 2016Unstable

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

  Patient problems: No Code Available

  MAUDE report 5538705 ↗
• InjuryMar 22, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING SCAR TISSUE; THE SURGEON WENT IN AND REMOVED THE SCAR TISSUE.

  Patient problems: Scar Tissue

  MAUDE report 5516767 ↗
• InjuryJan 14, 2016Unstable

  REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 5368997 ↗

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