DJO SURGICAL 391-09-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912118989), received between Jan 4, 2016 and Nov 16, 2024 — classified as 13 injuries.

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

• InjuryNov 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 20701576 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD AN INFECTION, POLY 3D 8X9 WAS REMOVED, WOUND WAS WASHED OUT AND POLY WAS REPLACED BY AN 8X11 INSERT.

  Patient problems: Medical device site infection

  MAUDE report 15840456 ↗
• InjuryJan 27, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: ORIGINAL POLY WAS REMOVED BECAUSE IT WAS COMPRESSED, CAUSING LEAKAGE INTO THE SCREW HOLES CAUSING OSTEOLYSIS. SCREWS WERE REMOVED AND HOLES WERE PLUGGED. A NEW 8/11 POLY WAS IMPLANTED.

  Patient problems: Osteolysis

  MAUDE report 13372126 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD FLEXION CONTRACTURE. REMOVED INSERT AND EXCISED SCAR TISSUE AND INSERTED NEW IMPLANT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Scar Tissue

  MAUDE report 13046934 ↗
• InjuryJun 2, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - IRRIGATION AND DRAINAGE FOR AN INFECTION, REPLACED INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 11919127 ↗
• InjuryApr 8, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - UNSTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9938664 ↗
• InjuryNov 20, 2019Unstable

  REVISION SURGERY - THE PATIENT KNEE HAD BECOME UNSTABLE, A LARGER INSERT WAS IMPLANTED TO STABILIZE THE KNEE.

  Patient problems: Failure of Implant

  MAUDE report 9349524 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO AN UNKNOWN REASON.

  Patient problems: No Code Available

  MAUDE report 8343637 ↗
• InjuryApr 4, 2018Device Operates Differently Than Expected

  REPORTED INCIDENT - DUE TO LEFT KNEE STIFFNESS WITH LOSS OF RANGE OF MOTION.

  Patient problems: Loss of Range of Motion

  MAUDE report 7397366 ↗
• InjuryAug 18, 2017Failure to Align

  REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING TIBIA MAL-ALIGNMENT.

  Patient problems: No Code Available

  MAUDE report 6805853 ↗
• InjuryJul 7, 2017Unstable

  REVISION SURGERY - DUE TO THE PATIENT HAVING KNEE INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 6695123 ↗
• InjuryMar 10, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO AN INFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 5493365 ↗
• InjuryJan 4, 2016Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - UNRELATED, NO SPECIFIC INFECTION OF THE JOINT.

  Patient problems: No Code Available

  MAUDE report 5340894 ↗

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