DJO SURGICAL 392-09-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912120265), received between Jan 20, 2016 and Nov 11, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  REVISION SURGERY - DUE TO BACKED OUT SCREW IN POLY.

  Patient problems: Failure of Implant

  MAUDE report 23528621 ↗
• InjuryApr 25, 2025Unstable; 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 21915080 ↗
• InjuryJun 7, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 14622397 ↗
• InjuryDec 17, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13030245 ↗
• InjuryJan 21, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY, CHANGED TO THICKER POLY.

  Patient problems: Insufficient Information

  MAUDE report 11210782 ↗
• InjuryDec 4, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT HAD AN INFECTION. THE SURGEON WASHED OUT THE KNEE AND REPLACED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 10946052 ↗
• InjuryJan 16, 2020Unstable

  REVISION SURGERY - DUE TO PATIENT COMPLAINING OF PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 9598145 ↗
• InjuryJun 5, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE IMPLANT HAVING NOT NORMAL MARKS AFTER 6 MONTHS OF USE. THE ABRASION IS NOT NORMAL FOR 6 MONTHS.

  Patient problems: Abrasion

  MAUDE report 8672699 ↗
• InjuryMay 8, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT HAVING PAIN. EVERYTHING BUT THE PATELLA WAS REMOVED. ANOTHER VENDOR'S ITEMS WERE PUT BACK IN.

  Patient problems: Pain

  MAUDE report 7495549 ↗
• InjuryJan 4, 2017Contamination

  REVISION SURGERY - DUE TO THE PATIENT BECOMING INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 6221935 ↗
• InjuryOct 6, 2016Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: DUE TO THE PATIENT HAVING BECOME UNSTABLE.

  Patient problems: No Code Available

  MAUDE report 6004885 ↗
• InjuryJul 26, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 5823073 ↗
• InjuryApr 13, 2016Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO FLEXION CONTRACTURE IN THE OPERATIVE KNEE.

  Patient problems: No Code Available

  MAUDE report 5574856 ↗
• InjuryJan 20, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION; THE SURGEON PERFORMED A WASH OUT AND REPLACED THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 5381717 ↗

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