DJO SURGICAL 391-09-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912118965), received between Sep 29, 2015 and Mar 7, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Unstable” (7 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.

• InjuryMar 7, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENT REPORTING STIFFNESS, LOSS OF ROM AND REVISED TIBIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 21554680 ↗
• InjuryApr 23, 2024Unstable; 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 19169672 ↗
• InjuryDec 29, 2023Adverse 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 18422517 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO IMPLANT WEAR.

  Patient problems: Joint Laxity

  MAUDE report 18188577 ↗
• InjuryApr 21, 2021Naturally Worn; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO POLY EXCHANGE DUE TO WEAR.

  Patient problems: Insufficient Information

  MAUDE report 11704183 ↗
• InjurySep 9, 2020Unstable

  REVISION SURGERY - PATIENT KNEE WAS UNSTABLE SO SURGEON REPLACED WITH THICKER INSERT AND ACHIEVED GREATER STABILITY.

  Patient problems: Insufficient Information

  MAUDE report 10511296 ↗
• InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10010273 ↗
• InjuryMar 3, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT'S KNEE BECAME UNSTABLE AND A THICKER INSERT NEEDED TO BE INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9779827 ↗
• InjuryJul 16, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - REVISION DUE TO INSTABILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8796370 ↗
• InjuryDec 4, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PUT IN BECAUSE AN INFECTION OCCURRED CAUSED BY DENTAL PROBLEMS. THIS COMPLAINT IS REPORTING THE 2ND STAGE SURGERY TO REMOVE AN ANTIBIOTIC CONSTRUCT, USED TO ALLEVIATE THE INFECTION AND IMPLANT NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8131047 ↗
• InjuryApr 11, 2018Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT BEING INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 7423402 ↗
• InjuryApr 4, 2018Unstable

  REPORTED INCIDENT - DUE TO LEFT KNEE INSTABILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397362 ↗
• InjuryFeb 19, 2018Unstable

  REVISION SURGERY - DUE TO INSTABILITY. THIS IS A STUDY SUBJECT PARTICIPATING IN THE (B)(6) STUDY RUN BY (B)(6). THE FEMORAL COMPONENT, BASEPLATE AND INSERT WERE ALL REMOVED. THE INVESTIGATOR FOR THE STUDY CONSIDERED THIS TO BE DEVICE RELATED.

  Patient problems: No Code Available

  MAUDE report 7281286 ↗
• InjuryJan 19, 2018Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7205447 ↗
• InjuryJun 23, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: DUE TO THE PATIENT'S KNEE BECOMING INFECTED; THE SURGEON REMOVED AND REPLACED THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 6665218 ↗
• InjurySep 29, 2015Insufficient Device Problem Information

  REVISION SURGERY - THE PATIENT'S JOINT WAS TIGHT AND REQUIRED THE REMOVAL OF SCAR TISSUE.

  Patient problems: No Code Available; Scarring

  MAUDE report 5111363 ↗

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