DJO SURGICAL 391-09-704Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912118941), received between Sep 29, 2017 and Jun 18, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Unstable” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO GROSSLY INFECTED REQUIRING REMOVAL OF COMPONENTS & PLACEMENT OF SPACER. FEMALE 71.

  Patient problems: Unspecified Infection

  MAUDE report 25553166 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO GENERAL WEAR OF ORIGINAL TIBIAL INSERT.

  Patient problems: Joint Laxity

  MAUDE report 16882503 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 16315176 ↗
• InjuryOct 12, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT STATED THAT SHE HAD UNDERWENT SEVERAL SESSIONS OF PHYSICAL THERAPY WITH LITTLE ALLEVIATION IN SYMPTOMS. KNEE HAS HAD ONGOING SWELLING AND DISCOMFORT. PATIENT NOTIFIED SURGEON OF POST OPERATIVE DISCOMFORT.

  Patient problems: Discomfort; Inflammation

  MAUDE report 12618958 ↗
• InjuryJan 5, 2021Loose or Intermittent Connection; Unstable

  REVISON SURGERY - PATIENT'S KNEE WAS BEING A LITTLE LOOSE/UNSTABLE. NEW THINNER INSERT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11120420 ↗
• InjuryJul 7, 2020Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - PATIENT KNEE WAS A LITTLE UNSTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10239555 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT HAD INFECTION IN KNEE. REMOVED AND EXCHANGED OUT THE INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 8955960 ↗
• InjurySep 29, 2017Unstable

  REVISION SURGERY - DUE TO PATIENT BECOMING UNSTABLE.

  Patient problems: No Code Available

  MAUDE report 6905089 ↗

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