DJO SURGICAL 392-13-704Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912120753), received between Aug 3, 2017 and Apr 22, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2019Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT FALLING AND STRETCHING OUT THE CRUCIATE LIGAMENTS AND NEEDING A THICKER INSERT.

  Patient problems: No Information

  MAUDE report 8536109 ↗
• InjuryApr 18, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO TIBIAL AND FEMORAL LOOSENING.

  Patient problems: No Information

  MAUDE report 8526928 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING PAIN RELATED TO OSTEOPHYTES.

  Patient problems: Pain

  MAUDE report 6764125 ↗

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