DJO SURGICAL 392-11-704Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912120517), received between Sep 11, 2015 and Feb 3, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Unstable” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24254951 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23004293 ↗
• InjuryMay 20, 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 22057604 ↗
• InjuryOct 25, 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 18008543 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - THE PATIENT FELL ON TO HER RIGHT KNEE AND SUSTAINED A DEHISCENCE OF THE INCISION WHICH EXPOSED THE KNEE JOINT IMPLANTS AND TORN THE EXTENSOR MECHANISM. REPRESENTATIVE WAS INFORMED BY SURGEON THAT HE WAS GOING SCHEDULE THE PATIENT FOR IRRIGATION & DRAINAGE TIBIAL INSERT EXCHANGE AND REPAIR OF THE EXTENSOR MECHANISM. THE TIBIAL INSERT WAS REMOVED AND A NEW TIBIAL INSERT OF THE SAME SIZE WAS IMPLANTED. THE REASON FOR THE REVISION SURGERY WAS NOT CAUSED BY THE IMPLANT. THE TIBIAL INSERT WAS EXCHANGED PROPHYLACTICALLY TO REDUCE THE RISK OF ACUTE INFECTION.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15581222 ↗
• InjuryApr 9, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PATIENT HAD A POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11645546 ↗
• InjurySep 1, 2020Unstable

  REVISION SURGERY - DUE TO PAIN, UNSTABLE, LOSS OF MOTION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 10476875 ↗
• InjuryApr 4, 2018Device Operates Differently Than Expected

  REPORTED INCIDENT - DUE TO RIGHT KNEE REDUCED RANGE OF MOTION.

  Patient problems: Loss of Range of Motion

  MAUDE report 7397365 ↗
• InjuryMar 16, 2018Unstable

  REVISION SURGERY - DUE TO THE PATIENT BECOMING UNSTABLE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7345385 ↗
• InjuryOct 26, 2017Unstable

  REVISION SURGERY - DUE TO THE PATIENT'S RIGHT KNEE HAVING INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 6980068 ↗
• InjuryJun 16, 2017Loose or Intermittent Connection

  REVISION SURGERY - DUE TO BILATERAL KNEE PAIN. THE FEMUR ON LEFT SIDE WAS LOOSE. A POLY INSERT EXCHANGE WAS DONE ON THE RIGHT KNEE; THE SURGEON WENT UP A SIZE. THIS COMPLAINT IS REPORTING ON THE PATIENT'S RIGHT SIDE SURGERY.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 6647753 ↗
• InjuryNov 30, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6136817 ↗
• InjurySep 11, 2015Loose or Intermittent Connection; Unstable

  REVISION SURGERY - DUE TO INSTABILITY; SUSPECTED TO BE CAUSED BY LIGAMENTOUS LOOSENING.

  Patient problems: No Code Available

  MAUDE report 5070966 ↗

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