DJO SURGICAL 391-09-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912118996), received between Sep 14, 2017 and Apr 23, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 19169665 ↗
• InjuryOct 14, 2020Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY - PATIENT WAS LOOSE, SWITCHED FROM 9MM TO A 13MM POLY.

  Patient problems: No Code Available

  MAUDE report 10680485 ↗
• InjuryJun 23, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10184952 ↗
• InjuryJan 13, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY, PATIENT HAD INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9581584 ↗
• InjuryDec 6, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - ACUTE INFECTION, SURGEON PERFORMED IRRIGATION AND DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 9431725 ↗
• InjuryDec 18, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE TIBIAL LOOSENING AND SIGNIFICANT POLY COMPRESSION. THE PATIENT HAD OSTEOLYSIS FROM THE POLY THROUGH THE SCREW HOLES.

  Patient problems: Osteolysis

  MAUDE report 8175067 ↗
• InjuryApr 30, 2018Naturally Worn

  REVISION SURGERY - DUE TO THE MEDIAL PORTION OF THE POLY BEING WORN AND NEEDING TO BE REPLACED.

  Patient problems: No Code Available

  MAUDE report 7472512 ↗
• InjuryMar 5, 2018Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7314727 ↗
• InjurySep 27, 2017Unstable

  REVISION SURGERY - THE SURGEON FOUND THE PATIENT HAD SOME INSTABILITY AND PUT IN A THICKER INSERT.

  Patient problems: No Code Available

  MAUDE report 6898528 ↗
• InjurySep 14, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO PATIENT FALLING, SURGEON CHOSE TO CHANGE THE INSERT.

  Patient problems: Fall

  MAUDE report 6865469 ↗

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