DJO SURGICAL 392-09-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912120296), received between Apr 20, 2016 and Jan 11, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE PATIENT PRESENTED WITH INSTABILITY AND PAIN. OPTED FOR A REVISION SURGERY TO ACHIEVE GREATER STABILITY.

  Patient problems: Pain

  MAUDE report 13231681 ↗
• InjuryOct 10, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN AROUND HIS PATELLA FROM THE TOTAL KNEE SURGERY THAT WAS DONE A COUPLE OF YEARS AGO. THE SURGEON WENT IN AND REMOVED A LOT OF SCAR TISSUE AND CHECKED ALL COMPONENTS. ALL COMPONENTS WERE FINE. THE SURGEON DECIDED TO REPLACE THE POLY INSERT AS A PRECAUTIONARY MEASURE.

  Patient problems: Pain; Scarring

  MAUDE report 6938478 ↗
• InjurySep 6, 2016Insufficient Device Problem Information

  REVISION SURGERY DUE TO AN INFECTION. THERE WAS AN ANTIBIOTIC SPACER IN THE PATIENT, ALL OF THE COMPONENTS HAD BEEN REMOVED PREVIOUSLY.

  Patient problems: Unspecified Infection

  MAUDE report 5930854 ↗
• InjuryApr 20, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING EXCESSIVE SCAR TISSUE BUILT UP AROUND THE KNEE. AFTER REMOVING IT, THE SURGEON FELT IT WAS NECESSARY TO EXCHANGE THE POLYETHYLENE INSERT.

  Patient problems: Scar Tissue

  MAUDE report 5592190 ↗

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