DJO SURGICAL 392-11-708Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912120555), received between Feb 11, 2016 and Sep 15, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17761628 ↗
• InjuryMar 30, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13955928 ↗
• InjuryDec 13, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO A FALL PATIENT TORE POSTERIOR CRUCIATE LIGAMENT, CAUSING INSTABILITY. A THICKER POLY WAS IMPLANTED 15MM AND STABILITY WAS ACHIEVED. IN ADDITION, OSTEOLYSIS WAS OCCURRING IN THE JOINT CAPSULE DUE TO EXISTING POLY WEAR.

  Patient problems: Fall; Osteolysis

  MAUDE report 12987002 ↗
• InjuryJul 16, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO PATIENT WAS UNSTABLE.

  Patient problems: Insufficient Information

  MAUDE report 12185676 ↗
• InjuryNov 20, 2018Unstable

  REVISION SURGERY - DUE TO THE PATIENT DEVELOPING INSTABILITY. THE SURGEON PUT IN A THICKER POLY.

  Patient problems: Failure of Implant

  MAUDE report 8091280 ↗
• InjuryNov 1, 2018Loose or Intermittent Connection

  REVISION SURGERY - DUE TO THE POLY BEING LOOSE.

  Patient problems: No Code Available

  MAUDE report 8028793 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY. DUE TO AN INFECTION, WASH OUT, AND POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 6623951 ↗
• InjuryMay 30, 2017Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT DEVELOPING FLEXION CONTRACTURE AFTER THE PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) AND WAS UNABLE TO BEND THEIR KNEE ENOUGH; REQUIRING SURGICAL LYSIS OF ADHESIONS TODAY. THE SURGEON REPLACED THE 11MM POLY INSERT WITH A THINNER 9MM INSERT TO HELP THE PATIENT REGAIN THE MOTION HE HAD DIFFICULTY WITH, SO HE CAN REGAIN HIS FLEXION. THE POLY EXCHANGE WENT SMOOTHLY.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 6599831 ↗
• InjuryApr 10, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON PERFORMED A WASH OUT AND POLY SWAP.

  Patient problems: Unspecified Infection

  MAUDE report 5566232 ↗
• InjuryFeb 11, 2016Inadequacy of Device Shape and/or Size

  REVISION SURGERY - DUE TO THE PATIENT PRESENTING POST-OPERATIVELY WITH POOR RANGE OF MOTION. THE SURGEON DETERMINED A THINNER INSERT AND REPLACEMENT OF PATELLA WOULD IMPROVE RANGE OF MOTION.

  Patient problems: Loss of Range of Motion

  MAUDE report 5431387 ↗

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