DJO SURGICAL 391-11-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912119221), received between Dec 22, 2016 and Sep 8, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION PATIENT REQUIRED REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 22994973 ↗
• InjuryJun 5, 2025Adverse 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 22155441 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO JOINT LAXITY AND POLY WEAR.

  Patient problems: Joint Laxity

  MAUDE report 22015252 ↗
• InjuryApr 3, 2025Adverse 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 21770250 ↗
• InjurySep 18, 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 20252803 ↗
• InjurySep 17, 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 20242858 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PAIN/INFECTION.

  Patient problems: Arthralgia; Unspecified Infection

  MAUDE report 17212576 ↗
• InjuryApr 22, 2020Loose or Intermittent Connection

  REVISION SURGERY - PATIENT WAS UNSTABLE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9987988 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT BEING INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 7616533 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT FALLING AND FEELING PAIN. THE SURGEON WENT IN AND REPLACED THE INSERT WITH A THICKER ONE.

  Patient problems: Fall; No Code Available; Pain

  MAUDE report 7422419 ↗
• InjuryOct 26, 2017Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO AN IRRIGATION AND DRAINAGE OF THE PATIENT'S TOTAL KNEE, AND THE SURGEON SWAPPING THE POLY.

  Patient problems: Failure of Implant; Fluid Discharge

  MAUDE report 6980833 ↗
• InjuryJun 15, 2017Loose or Intermittent Connection; Unstable

  REVISION SURGERY: DUE TO THE PATIENT HAVING PRESENTED WITH LIGAMENT LAXITY AND INSTABILITY. THE SURGEON DECIDED A THICKER POLY WOULD RESOLVE THE LIGAMENT ISSUE.

  Patient problems: No Code Available

  MAUDE report 6645587 ↗
• MalfunctionMar 31, 2017Device Markings/Labelling Problem

  PRIMARY SURGERY - THERE WAS A SIZE 8 INSERT INSIDE A SIZE 6 BOX.

  Patient problems: No Information

  MAUDE report 6451313 ↗
• InjuryDec 22, 2016Device Operates Differently Than Expected

  REVISION SURGERY - DUE TO THE PATIENT BECOMING UNSTABLE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 6199473 ↗

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