DJO SURGICAL 392-09-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888912120258), received between Sep 30, 2015 and Sep 26, 2023 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - HYPEREXTENSION.

  Patient problems: Joint Laxity

  MAUDE report 17822418 ↗
• InjuryJul 13, 2022Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15001919 ↗
• InjuryDec 9, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Insufficient Information

  MAUDE report 12968104 ↗
• InjurySep 17, 2021Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - REMOVED AND REPLACED THE INSERT DUE TO INSTABILITY IN THE KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12492046 ↗
• InjurySep 27, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Failure of Implant

  MAUDE report 9130287 ↗
• InjuryMay 20, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING PAIN BECAUSE OF TIBIAL LOOSENING.

  Patient problems: Pain

  MAUDE report 8626264 ↗
• InjuryNov 16, 2017Unstable

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 7038954 ↗
• InjuryJul 17, 2017Fracture

  REVISION SURGERY - DUE TO THE PATIENT FALLING AND FRACTURING. THE SURGEON HAD TO REMOVE A COMPETITOR'S PLATE AND SWAPPED OUT THE POLY TO BE SAFE.

  Patient problems: Fall

  MAUDE report 6717479 ↗
• InjuryJun 7, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 6619026 ↗
• InjuryJan 6, 2016Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY: DUE TO THE PATIENT'S JOINT HAVING EXCESS SCAR TISSUE; INHIBITING THE PATIENT'S RANGE OF MOTION.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 5349023 ↗
• InjuryJan 4, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON CHANGED OUT THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 5340940 ↗
• InjurySep 30, 2015Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 5113471 ↗

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-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-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-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